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NCT03896646 · ClinicalTrials.gov registry record · NA
Radioembolization for HCC Patients With Personalized Yttrium-90 Dosimetry for Curative Intent (RAPY90D)
A NA study of Stage III Hepatocellular Carcinoma AJCC v8 and Stage IV Hepatocellular Carcinoma AJCC v8, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- NA
- Development phase
- 42
- Enrollment target
- 1
- Study location
NCT03896646: Active NA study of Stage III Hepatocellular Carcinoma AJCC v8 and Stage IV Hepatocellular Carcinoma AJCC v8, sponsored by M.D. Anderson Cancer Center.
NCT03896646 is a NA study of Stage III Hepatocellular Carcinoma AJCC v8 and Stage IV Hepatocellular Carcinoma AJCC v8 that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 42 participants, below the 57-participant average among 14 other Stage III Hepatocellular Carcinoma AJCC v8 trials with a reported enrollment target (26% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03896646, a NA study of Stage III Hepatocellular Carcinoma AJCC v8 and Stage IV Hepatocellular Carcinoma AJCC v8, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 42 participants
- Enrollment target
- 1
- Study location
Study Summary
This trial aims to improve hepatocellular carcinoma (HCC) tumor responses in patients undergoing Y90 radioembolization by using personalized dosimetry as part of treatment planning. Using standard calculations for Y90 doses may not be specific enough for individual patients given that there can be differences in how tumor cells and liver cells respond to radiation. Personalized dose plans may help improve treatment and outcomes in liver cancer.
Primary Outcome
Assessed with modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria. The ORR of treated tumors will be determined. Will perform a cluster bootstrap in which patients (not tumors) are sampled with replacement. Will construct a 95% confidence interval using the 2.5% and 97.5% quantiles of the bootstrap sampling distribution.
Conditions Studied
Interventions
- PROCEDURE Computed Tomography
- PROCEDURE Single Photon Emission Computed Tomography
- OTHER Hepatobiliary Iminodiacetic Acid Scan
- RADIATION Yttrium Y 90 Glass Microspheres
- PROCEDURE Yttrium-90 Microsphere Radioembolization
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2019-10-10 |
| Est. Completion | 2026-09-30 |
| Phase | NA |
What the registry record for NCT03896646 still lists
NCT03896646 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 57-participant average among 14 other Stage III Hepatocellular Carcinoma AJCC v8 trials with a reported enrollment target (26% lower).
The record links to 7 conditions, with Stage III Hepatocellular Carcinoma AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Computed Tomography is the first listed.
NCT03896646 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03896646 about?
NCT03896646 is a clinical study titled "Radioembolization for HCC Patients With Personalized Yttrium-90 Dosimetry for Curative Intent (RAPY90D)". This trial aims to improve hepatocellular carcinoma (HCC) tumor responses in patients undergoing Y90 radioembolization by using personalized dosimetry as part of treatment planning. Using standard calculations for Y90 doses may not be specific enough for individual patients given that there can be d...
What is the current status of trial NCT03896646?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 42 participants. The study started on 2019-10-10. Estimated completion is 2026-09-30.
What conditions does trial NCT03896646 study?
This clinical trial studies the following conditions: Stage III Hepatocellular Carcinoma AJCC v8, Stage IV Hepatocellular Carcinoma AJCC v8, Unresectable Hepatocellular Carcinoma, Stage IIIA Hepatocellular Carcinoma AJCC V8, Stage IVA Hepatocellular Carcinoma AJCC V8.
What interventions are being tested in trial NCT03896646?
The interventions under investigation include: Computed Tomography (PROCEDURE), Single Photon Emission Computed Tomography (PROCEDURE), Hepatobiliary Iminodiacetic Acid Scan (OTHER), Yttrium Y 90 Glass Microspheres (RADIATION), Yttrium-90 Microsphere Radioembolization (PROCEDURE).
Who is sponsoring clinical trial NCT03896646?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03896646 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03896646's enrollment target sits among peer trials
42 5th of 14 higher than 10 of 14 other Stage III Hepatocellular Carcinoma AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage III Hepatocellular Carcinoma AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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