Comparison · NCT02181075-b707c78e
Part I (Patients Enrolled Between March 2015-April 2017) vs Part II (Patients Enrolled Between June 2016-Feb 2017): Persistence of Cell Viability Stain Post-LTLD+FUS
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Part I (Patients Enrolled Between March 2015-April 2017) vs Part II (Patients Enrolled Between June 2016-Feb 2017): Persistence of Cell Viability Stain Post-LTLD+FUS. Trial comparisons, record NCT02181075-b707c78e. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02181075-b707c78e
On this page
Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 1 | 0.566 | 1 | wilson | |
| Risk in group 2 | 0.75 | 0.301 | 0.954 | wilson | |
| Risk difference, group 1 minus group 2 | 0.25 | -0.23 | 0.699 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.33 | 0.757 | 2.35 | log | |
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one more participant with the outcome on Part I (Patients Enrolled Between March 2015-April 2017) than on Part II (Patients Enrolled Between June 2016-Feb 2017) | 4 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Part I (Patients Enrolled Between March 2015-April 2017) | Arm 1 - see above | 5 | 5 | OG000 |
| Group 2 | Part II (Patients Enrolled Between June 2016-Feb 2017) | Arm 2 - see above | 3 | 4 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Persistence of Cell Viability Stain Post-LTLD+FUS
- Description
Post-LTLD+FUS tissue from the targeted liver tumours was obtained by biopsy at the time of the intervention, between 24/03/2015 and 29/03/2017. Cytokeratin-8 (CK-8) is a cell viability marker which if present, demonstrates lack of ablative cell death by any ablative modality, including FUS.~Not all histological cell types express CK8, thus if the Post-LTLD+FUS it may either indicate:~i) Non-CK8 expression ii) Thermal ablation and consequent cell death.~Note there was uncertainty about CK8 expression of individual patient tumours prior to recruitment. In this study if the Post-LTLD+FUS tissue shows specific cellular CK8 cellular staining, then it demonstrates that i) the tumour is CK8+, and, ii) the tumour was not instantaneously thermally ablated and any subsequent cell death is likely due to drug delivery/chemo-ablation.~For more information see key TARDOX Lancet Oncology publication and Cytokeratin 8 reference (both detailed in References section).
- Time frame
- Tissue obtained on day of intervention (Day 1). All CK8 cell viability staining was performed within 2 months of sampling.
- Population
5/6 Part I patients and 4/4 Part II patients had tissue which was analysable for CK-8. The Outcome Measure Data Table demonstrates the number of patients from each arm having CK-8 positive tumour biopsy samples post-LTLD+FUS, indicating lack of thermal ablation (which is consistent with desired hyperthermia rather than undesirable FUS ablation).
Source ClinicalTrials.gov
Trial
- Title
- Targeted Chemotherapy Using Focused Ultrasound for Liver Tumours
- NCT number
- NCT02181075
- Phases
- PHASE1
- Conditions
- Liver Tumour
- Interventions
ThermoDox® (LTLD), Focused Ultrasound of Target Liver Tumour, Pre-LTLD Biopsy of Target Liver Tumour, Post-LTLD Biopsy of Target Liver Tumour, Post-LTLD+FUS (Post-FUS) Biopsy of Target Liver Tumour, Thermometry of Target Tumour
- Lead sponsor
- University of Oxford
- Results first posted
- 2019-06-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02181075?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT02181075-b707c78e