This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Contrast-enhanced Ultrasound Evaluation of Chemoembolization (NCT02764801), a na phase 3 study. The primary outcome is Percentage of Patients Correctly Identified as Requiring Tumor Re-treatment Two Weeks After Initial Chemoembolization.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02764801 |
| Phase | Phase 3 |
| Condition | Hepatocellular Carcinoma, Chemoembolization, Therapeutic |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 131 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University |
| Results posted | Yes |
2. Clinical Question
Population
The trial concerns patients with hepatocellular carcinoma who received transarterial chemoembolization (TACE). The registry record lists an enrollment of 131, but does not describe the participants’ baseline characteristics, eligibility details, or the number who contributed data to the primary endpoint.
Intervention
The intervention was contrast-enhanced ultrasound using an ultrasound contrast agent and a Logiq E9 Scanner. The registry objective describes both 2D and 4D contrast-enhanced ultrasound assessments after TACE.
Comparator
The registry lists a single contrast ultrasound arm and no randomized comparison. The brief summary names contrast-enhanced MRI or CT as imaging approaches for which ultrasound is being evaluated as an alternative, but the record does not establish a concurrent MRI or CT control arm.
Primary question
Can contrast-enhanced ultrasound correctly identify patients who require tumor re-treatment because residual disease remains after chemoembolization? The primary outcome is framed as the percentage correctly identified 1-2 weeks after treatment, with the endpoint title specifying two weeks. The brief summary also describes an objective to evaluate sensitivity and specificity at 1-2 weeks and 1 month. Numerical results for these diagnostic measures are not reported in the registry record.
This is a diagnostic-monitoring question, rather than a comparison of treatment effects between randomized groups. The clinical purpose described in the record is to assess whether ultrasound can identify residual disease after TACE and thereby inform the need for re-treatment. The registry does not report how ultrasound classifications were verified, who made the re-treatment determination, or how disagreement between imaging assessments was handled. Those details matter when interpreting accuracy: sensitivity and specificity depend on how disease status and a positive or negative assessment are defined. The record establishes the intended question, but not enough operational detail to reconstruct the diagnostic classification process or judge the accuracy of the assessments.
3. Trial Design
The registry describes NCT02764801, titled “Contrast-enhanced Ultrasound Evaluation of Chemoembolization,” as a completed Phase 3 study sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University. The listed start is 2016-04, primary completion is 2021-12, and enrollment is 131. The conditions are hepatocellular carcinoma and therapeutic chemoembolization.
The design is single-group, with allocation listed as NA and masking listed as NONE. The sole described arm is the Contrast Ultrasound Arm, consisting of patients receiving contrast-enhanced ultrasound for diagnosis of chemoembolization response. The interventions are an ultrasound contrast agent and the Logiq E9 Scanner. This structure is important: the study does not present a randomized comparison between ultrasound and MRI or CT, even though MRI and CT appear in the objective as existing imaging approaches against which ultrasound is considered as an alternative.
The registry’s brief summary sets out an objective to evaluate sensitivity and specificity of 2D and 4D contrast-enhanced ultrasound for monitoring response at 1-2 weeks and 1 month after TACE. The listed primary outcome is narrower in its wording: the percentage of patients correctly identified as requiring tumor re-treatment two weeks after initial chemoembolization, with a timeframe described as 1-2 weeks after the procedure. The record lists two outcome measures and no analyses. It does not report the recruitment flow, the number assessed at each time point, or whether every enrolled participant received both ultrasound approaches. The protocol details, sample-size justification, and statistical analysis plan are not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Contrast Ultrasound Arm |
|---|---|
| STARTED | 131 |
| COMPLETED | 103 |
| NOT COMPLETED | 28 |
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Contrast Ultrasound Arm |
|---|---|---|
| Participants analysed | 131 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 131 |
| Age, Categorical: >=65 years | Participants | 0 |
| Sex: Female, Male: Female | Participants | 25 |
| Sex: Female, Male: Male | Participants | 106 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 21 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 110 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 13 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 19 |
| Race (NIH/OMB): White | Participants | 78 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 21 |
| Region of Enrollment: United States | participants | 131 |
6. Primary Endpoint
The registry lists the primary outcome as Percentage of Patients Correctly Identified as Requiring Tumor Re-treatment Two Weeks After Initial Chemoembolization, measured over Percentage of patients correctly identified as requiring re-treatment will be identified 1-2 weeks after the subject's chemoembolization procedure.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 95% Confidence Interval |
| Unit | percentage |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint concerns the percentage of patients correctly identified as requiring tumor re-treatment after initial chemoembolization. Its stated rationale is that contrast-enhanced ultrasound may detect residual disease, which is linked in the endpoint description to the need for re-treatment. The timeframe is stated as 1-2 weeks after the procedure, while the endpoint title names two weeks. The brief summary also refers to assessment at 1 month, but that later assessment is not the timeframe named in the primary outcome title.
Correct identification is a broad accuracy measure. In general, sensitivity describes how often a test identifies disease when disease is present, while specificity describes how often it classifies disease as absent when it is absent. The registry’s objective mentions both measures, but the primary outcome is worded as a percentage correctly identified. It does not specify in the record how “correctly identified” was calculated, what reference assessment established residual disease, or whether the percentage combines positive and negative classifications. Those definitions are needed to interpret the endpoint as a diagnostic accuracy estimate.
The primary outcome lists a 95% Confidence Interval as its dispersion measure. A confidence interval communicates uncertainty around an estimated quantity; its width depends on the amount and variability of the data as well as the analysis. No endpoint estimate or interval is reported in the registry record, so the accuracy and precision of the primary outcome cannot be assessed from the posted results.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies an important statistical distinction between the intended question and the available results. It describes an objective to evaluate 2D and 4D contrast-enhanced ultrasound for monitoring TACE response, including sensitivity and specificity assessments at 1-2 weeks and 1 month. It also names a primary outcome focused on the percentage correctly identified as requiring re-treatment at two weeks. However, no numerical primary outcome result is reported in the registry record. Sensitivity, specificity, the percentage correctly identified, and the associated 95% confidence interval are therefore not available for interpretation.
Without an estimate and its uncertainty, it is not possible to assess how frequently ultrasound classifications agreed with the disease status used in the study, or how precisely that agreement was estimated. A confidence interval is particularly useful for distinguishing a narrowly estimated result from one compatible with a wide range of values. The endpoint lists a 95% confidence interval as the planned dispersion measure, but the registry does not give its limits. Consequently, there is no basis in the posted results for judging whether the primary estimate was precise, whether estimates differed across the stated ultrasound approaches, or whether findings changed between the assessment times.
The study is single-group and has no randomized control arm. The registry’s reference to MRI or CT is part of the objective’s framing of ultrasound as an alternative; it does not establish that the trial directly compared ultrasound with either modality in parallel. The record therefore does not support a comparative estimate of diagnostic performance between ultrasound and MRI or CT. Nor does it report a treatment-effect comparison, because no intervention control group is described.
The registry lists enrollment of 131 and safety denominators of 103 in the contrast ultrasound arm. The record does not explain the difference between those counts. They should not be treated as interchangeable denominators: enrollment does not establish how many participants had evaluable endpoint data, and the safety counts do not by themselves establish the analysis population for diagnostic accuracy.
There are two listed outcome measures and no analyses listed. This absence does not establish that no analyses were conducted; it means the registry record does not present analysis results. The sample-size illustrations associated with the posted material are planning scenarios based on an observed effect, not observed power or trial results. Their assumptions include a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, although the actual study is single-group. Such scenarios cannot substitute for the missing endpoint estimate, uncertainty interval, or a documented justification of the trial’s enrollment target. Overall, the record supports a description of the study’s intent and design, but not a conclusion about the observed diagnostic accuracy of contrast-enhanced ultrasound.
9. Statistical Methods Explained
The primary endpoint is presented as a percentage of patients correctly identified as requiring tumor re-treatment after chemoembolization. The registry also states that sensitivity and specificity are objectives. These concepts are related but not interchangeable. In general, sensitivity is the proportion of people with the target condition who are classified as positive by a test. Specificity is the proportion without the target condition who are classified as negative. A total percentage correctly identified combines information about positive and negative classifications and can depend on how common the target condition is in the assessed population. The record does not give the operational definitions or the reference standard used for these classifications.
What would a confidence interval convey?
The primary outcome names a 95% confidence interval. In general, a confidence interval describes statistical uncertainty around an estimate under the assumptions of the analysis. A narrower interval indicates greater precision, while a wider interval indicates more uncertainty. Its interpretation depends on the estimate, the data contributing to it, and the method used to calculate it. Neither the primary percentage nor its confidence interval is reported in the registry record. As a result, the endpoint cannot be evaluated for either magnitude or precision using the posted registry information.
Why does the reference standard matter?
Diagnostic accuracy requires a basis for deciding whether residual disease is truly present. In general, a test classification is compared with a reference assessment that serves as the basis for determining disease status. The registry describes contrast-enhanced ultrasound as a way to detect residual disease and mentions MRI or CT in the objective, but does not report how the reference status was established, whether MRI or CT served that role, or whether assessments were reviewed independently. These omissions prevent reconstruction of the underlying classification counts and assessment of possible review or verification differences.
The timing and definition of the target also matter. The primary outcome title refers to two weeks after initial chemoembolization, while its timeframe states 1-2 weeks. The brief summary describes evaluation at 1-2 weeks and 1 month. If accuracy is assessed at more than one time or with more than one ultrasound approach, the timing and classification rules should be clear for each analysis. The registry record does not report those detailed rules or the results for the stated assessments.
What can a single-group design estimate?
A single-group diagnostic study can describe performance in the assessed participants if the diagnostic methods, reference standard, and analysis population are specified. It does not, by itself, provide a randomized comparison with another imaging approach. Here, allocation is listed as NA, masking as NONE, and the model as SINGLE GROUP. The registry lists one contrast ultrasound arm. Thus, the record does not establish a head-to-head comparison with MRI or CT, despite naming those modalities in the objective. Without a concurrent comparator and comparable assessment procedures, differences in performance between modalities cannot be estimated from this design as described.
Masking can matter in diagnostic studies because knowledge of one assessment may influence interpretation of another. General methods practice distinguishes blinded reading from unmasked assessment, but the registry lists no masking. It does not say which readers knew other imaging findings or clinical information, whether separate readers assessed each method, or how disagreements were resolved. The absence of reported details limits evaluation of the risk that interpretation was influenced by information beyond the ultrasound images.
How should sample-size illustrations be read?
Sample-size illustrations are planning calculations, not findings from the trial. The stated illustration assumptions use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the target effect is expressed as a stated fraction of the observed effect. The posted descriptions characterize the figures as planning illustrations computed from the observed effect, not as the trial’s own design. Because the actual study is single-group, the equal-allocation, two-arm framework does not mirror the design described in the registry. The illustrations should therefore be read as hypothetical planning scenarios rather than as a record of the enrollment rationale or the study’s achieved ability to detect an effect.
Observed power is not a substitute for an estimate and confidence interval. In general, planning power concerns the probability of detecting a specified effect under chosen assumptions before data are collected. It does not reveal the precision of the observed estimate after the study. The registry does not report a sample-size justification, the assumptions used to set enrollment, or an analysis plan that links the illustrations to the study design. No numerical sample-size illustration should be interpreted as an observed trial outcome.
What analysis details are absent?
The registry lists two outcome measures and zero analyses. It does not describe the statistical method for the primary endpoint, how incomplete or indeterminate ultrasound assessments were treated, or which participants formed the analysis population. It also does not report the number with evaluable assessments at each stated time point. In general, missing assessments can affect a diagnostic accuracy estimate if the likelihood of missingness is related to disease status or test results. The amount and handling of missing data are not reported in the registry record, so that possibility cannot be evaluated.
Over-dispersion is a general concern when count data vary more than a model assumes, but the record does not provide the endpoint counts, model, or analysis results needed to determine whether it is relevant to this study. More broadly, the registry does not report model diagnostics, adjustment variables, or sensitivity analyses. The available information supports explanation of the intended endpoint and design, but not independent reproduction of the statistical analysis.
10. Multiplicity, Missing Data and Analysis Populations
The brief summary describes assessment of 2D and 4D contrast-enhanced ultrasound at 1-2 weeks and 1 month after TACE. The listed primary outcome focuses on correct identification of patients requiring re-treatment at two weeks, with a timeframe of 1-2 weeks. These multiple approaches and assessment times could lead to multiple accuracy estimates. In general, when several hypotheses or endpoints are tested, the chance of at least one apparently notable result can increase unless the analysis plan addresses multiplicity. The registry does not report a multiplicity strategy, a hierarchy among the assessments, or which comparisons were confirmatory versus exploratory.
The record lists two outcome measures and no analyses. It does not provide a statistical analysis plan, analysis populations, or results that would show how the planned objectives were translated into analyses. It also does not report how missing, indeterminate, or technically inadequate assessments were handled, or how many participants contributed to each assessment. These details are important because a diagnostic accuracy estimate depends on which participants and classifications are included.
In general, missing data can create bias when participants without evaluable assessments differ systematically from those with complete data. The registry’s enrollment is 131, while the safety group lists 103 at risk; the reason for the differing denominators is not reported in the registry record. The safety denominator should not be assumed to be the primary endpoint population. The record also does not state whether all enrolled participants were expected to undergo both ultrasound formats or every follow-up assessment. Without the analysis population, missing-data handling, and multiplicity plan, statistical interpretation of the stated objectives remains limited.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Contrast Ultrasound Arm | 4 | 103 | 3.9% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Contrast Ultrasound Arm | 35 of 103 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Contrast Ultrasound Arm | 4 of 103 |
Most frequent serious adverse event terms
| Event term | Organ system | Contrast Ultrasound Arm |
|---|---|---|
| shortness of breath | Respiratory, thoracic and mediastinal disorders | 1 of 103 |
| episodic atrial fibrillation | Cardiac disorders | 1 of 103 |
| esophageal variceal bleeding | Respiratory, thoracic and mediastinal disorders | 1 of 103 |
| late dyspnea | Respiratory, thoracic and mediastinal disorders | 1 of 103 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Contrast Ultrasound Arm |
|---|---|---|
| post-embolization syndrome | General disorders | 2 of 103 |
| nausea/vomiting | Gastrointestinal disorders | 1 of 103 |
| IV infiltration | Product Issues | 1 of 103 |
Serious events with the highest arm-level rate: shortness of breath (1.0%), episodic atrial fibrillation (1.0%), esophageal variceal bleeding (1.0%), late dyspnea (1.0%).
The registry lists a Contrast Ultrasound Arm with 103 participants at risk for serious adverse events and 4 affected. It also lists 103 at risk for other adverse events and 4 affected. These are reported as separate categories; the record does not explain whether the affected participants overlapped between categories or how events were counted. Deaths are listed as 35. The registry does not report in this entry whether deaths were attributed to the intervention, the underlying condition, or another cause, nor does it give their timing or relationship to study procedures.
The most frequently listed serious-event terms are shortness of breath, episodic atrial fibrillation, esophageal variceal bleeding, and late dyspnea, each reported as 1.0%. These term-level percentages should be read as registry entries, not as evidence that the events were caused by contrast-enhanced ultrasound. The record does not provide event narratives, severity grades, relatedness assessments, or enough detail to determine whether terms refer to unique participants or event episodes.
Safety counts describe events recorded within the stated group and denominator; they do not establish comparative safety in the absence of a control group. The listed serious and other event counts also do not provide the diagnostic accuracy results. Their interpretation is constrained by the unreported event definitions, attribution, follow-up, and relationship between the enrollment and safety populations.
12. What the Result Does, and Does Not, Mean
The registry record establishes that the study was designed to examine contrast-enhanced ultrasound as a method for monitoring hepatocellular carcinoma response after TACE. It identifies a primary diagnostic question: whether patients requiring tumor re-treatment because of residual disease can be correctly identified around two weeks after the procedure. It also describes broader objectives involving 2D and 4D ultrasound and assessments at 1-2 weeks and 1 month.
That design description is not an accuracy result. The record does not report the percentage correctly identified, sensitivity, specificity, or the primary outcome’s 95% confidence interval. It therefore does not establish how often ultrasound classifications agreed with the study’s disease-status determination or how precisely any such estimate was measured. The completed status indicates that the study is listed as completed, but completion alone does not provide an endpoint result.
The single-group design also limits comparative conclusions. MRI and CT are named in the objective as imaging approaches for which ultrasound is considered as an alternative, but the registry does not describe a randomized MRI or CT comparison arm. The available record cannot establish that ultrasound performed better, worse, or similarly to either modality. It also cannot establish whether ultrasound changed re-treatment decisions or affected patient outcomes.
General interpretation of diagnostic testing depends on clear definitions of the target condition, the test threshold, the reference standard, and the analysis population. The registry does not report enough detail to reconstruct those elements. The safety entries describe events and deaths in the listed group, but do not establish that they were caused by the intervention or allow comparison with another group. The appropriate reading is therefore limited: the registry describes the intended diagnostic evaluation and reports safety counts, while the posted record does not report the primary diagnostic results needed to judge accuracy or comparative performance.
13. Why This Trial Matters Statistically
This trial raises statistical issues that are common in diagnostic research. The intended outcome is not a simple comparison of treatment groups; it asks whether an imaging assessment identifies residual disease and the need for re-treatment. That question relies on a well-defined reference standard and transparent classification rules. Without those details, even a reported percentage correctly identified can be difficult to interpret, because the composition of positive and negative classifications affects what the overall percentage represents.
The distinction between study objective and reported result is especially important. The registry describes sensitivity and specificity for 2D and 4D contrast-enhanced ultrasound at multiple assessment times, but lists no analyses and gives no primary outcome estimate. A completed study record can therefore describe what investigators intended to evaluate without establishing the diagnostic performance observed. Statistical interpretation requires both an estimate and information about its uncertainty and analysis population.
The design also illustrates why a stated alternative is not the same as a direct comparator. MRI and CT appear in the objective, but the listed design is single-group, with one contrast ultrasound arm and no randomized comparison. A head-to-head accuracy comparison would require appropriate paired or concurrent assessments and a prespecified approach to comparing them; those details are not reported in the registry record.
Finally, planning calculations must be separated from evidence generated by the trial. The posted sample-size descriptions are planning illustrations, not observed power, and their two-arm allocation assumption does not match the single-group design described. This example underscores the need to connect the design, estimand, analysis population, and uncertainty interval before drawing conclusions from diagnostic studies.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
Several limitations are specific to the information in this registry record. First, the primary outcome result is not reported. Neither the percentage correctly identified nor its 95% confidence interval is available, and the record does not give sensitivity or specificity estimates. Thus, the central diagnostic objective cannot be evaluated from the posted results.
Second, the design is single-group, with allocation listed as NA and masking listed as NONE. The record describes no concurrent MRI or CT control arm, so it does not support direct comparative conclusions. Although the objective frames ultrasound as an alternative to MRI or CT, the registry does not say whether those modalities were used as a reference assessment or how imaging findings were compared.
Third, endpoint definitions and operational details are incomplete. The record does not identify the reference standard for residual disease, the threshold for a positive ultrasound assessment, who determined the need for re-treatment, or how indeterminate assessments were handled. The endpoint title specifies two weeks, its timeframe states 1-2 weeks, and the brief summary also includes 1 month. The record does not explain whether timing windows differed across assessments or provide results by time point.
Fourth, the analysis population and missing-data handling are not reported. Enrollment is 131, whereas the safety group lists 103 at risk; the reason for the differing denominators is not reported in the registry record. These counts should not be used to infer how many participants contributed to diagnostic accuracy analyses. Finally, the registry lists two outcome measures and no analyses, and does not report a sample-size justification, multiplicity plan, or statistical analysis plan. These gaps limit assessment of precision, bias, and the relationship between the stated objectives and any analyses performed.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Contrast-enhanced Ultrasound Evaluation of Chemoembolization — NCT02764801.
- Registry record last updated 2025-05-06; status last verified 2025-05.
- Results first posted 2023-09-21.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT02764801 is a completed Phase 3, single-group study of contrast-enhanced ultrasound for evaluating response after chemoembolization in hepatocellular carcinoma. The sponsor is Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University. The registry lists enrollment of 131, a start of 2016-04, and primary completion in 2021-12. The study intervention includes an ultrasound contrast agent and a Logiq E9 Scanner, with one contrast ultrasound arm and no masking.
The primary outcome is the percentage correctly identified as requiring tumor re-treatment after initial chemoembolization, with a timeframe of 1-2 weeks and a title referring to two weeks. The broader objective mentions 2D and 4D assessments at 1-2 weeks and 1 month. The registry lists two outcome measures and no analyses. It does not report the primary accuracy estimate, sensitivity, specificity, or confidence interval. Safety entries list 103 at risk and 4 affected for serious adverse events, 103 at risk and 4 affected for other adverse events, and 35 deaths. These entries do not establish causality or comparative safety.