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NCT04518748 · ClinicalTrials.gov registry record · Phase 1
Combined Y-90 Selective Internal Radiation Therapy (Y-90 SIRT) and Stereotactic Body Radiation Therapy (SBRT) in Hepatic Malignancy.
A Phase 1 study of Liver Malignancy, sponsored by University of Michigan Rogel Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 70
- Enrollment target
- 1
- Study location
NCT04518748: Recruiting Phase 1 study of Liver Malignancy, sponsored by University of Michigan Rogel Cancer Center.
NCT04518748 is a Phase 1 study of Liver Malignancy that is actively recruiting participants, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 70 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04518748, a Phase 1 study of Liver Malignancy, is actively recruiting participants, sponsored by University of Michigan Rogel Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 70 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will investigate the combination of Ytrium-90 (Y-90) Selective Internal Radiation Therapy (SIRT) followed by Stereotactic Body Radiation Therapy (SBRT). Y-90 SIRT alone or SBRT alone are standard procedures used in the treatment of liver cancer. This study will assess the combination of Y-90 SIRT and SBRT and obtain preliminary information about the side effects and safety of the combination therapy. Additionally, this is the first time that Y-90 PET-CT imaging will be included in planning for SBRT.
Primary Outcome
The primary safety endpoint is the binary indicator for a CTP increase of 2 or more points within 6 months and relative to pre-SBRT baseline. An increase of 2 or more points indicates clinically significant liver decompensation.
Conditions Studied
Interventions
- RADIATION Stereotactic Body Radiation Therapy
- DIAGNOSTIC_TEST PET/CT
- DRUG Yttrium-90
- DEVICE Selective Internal Radiation Therapy
- DEVICE Therasphere
Study Locations (1)
Michigan
- University of Michigan Rogel Cancer Center - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2020-09-16 |
| Est. Completion | 2028-11 |
| Phase | Phase 1 |
What NCT04518748 shows while recruiting
NCT04518748 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% higher).
The record links to 1 condition, with Liver Malignancy appearing as the primary indexed condition, and to 5 interventions - of which Stereotactic Body Radiation Therapy is the first listed.
NCT04518748 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT04518748 about?
NCT04518748 is a clinical study titled "Combined Y-90 Selective Internal Radiation Therapy (Y-90 SIRT) and Stereotactic Body Radiation Therapy (SBRT) in Hepatic Malignancy.". This study will investigate the combination of Ytrium-90 (Y-90) Selective Internal Radiation Therapy (SIRT) followed by Stereotactic Body Radiation Therapy (SBRT). Y-90 SIRT alone or SBRT alone are standard procedures used in the treatment of liver cancer. This study will assess the combination of Y...
What is the current status of trial NCT04518748?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 70 participants. The study started on 2020-09-16. Estimated completion is 2028-11.
What conditions does trial NCT04518748 study?
This clinical trial studies the following conditions: Liver Malignancy.
What interventions are being tested in trial NCT04518748?
The interventions under investigation include: Stereotactic Body Radiation Therapy (RADIATION), PET/CT (DIAGNOSTIC_TEST), Yttrium-90 (DRUG), Selective Internal Radiation Therapy (DEVICE), Therasphere (DEVICE).
Who is sponsoring clinical trial NCT04518748?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04518748 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04518748's enrollment target sits among peer trials
70 749th of 2000 higher than 1,227 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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