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NCT01473004 · ClinicalTrials.gov registry record · Phase 2
SIR-Spheres® 90Y Microspheres Treatment of Uveal Melanoma Metastasized to Liver
A Phase 2 study of Stage IV Uveal Melanoma, sponsored by Thomas Jefferson University.
- Completed
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
- 1
- Study location
NCT01473004: Completed Phase 2 study of Stage IV Uveal Melanoma, sponsored by Thomas Jefferson University.
NCT01473004 is a Phase 2 study of Stage IV Uveal Melanoma that has completed, run by Thomas Jefferson University. The registered enrollment target is 48 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01473004, a Phase 2 study of Stage IV Uveal Melanoma, has completed, sponsored by Thomas Jefferson University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to determine whether radiation provided locally to the liver tumor vasculature environment will demonstrate a response of tumor decline. This radiation may cause the tumor cells to die. This is a phase II clinical trial to investigate safety and efficacy of radioactive microsphere (SIR-Spheres® microspheres). Uveal melanoma patients with progressing hepatic metastases who received no more than one intra-hepatic arterial treatment will be enrolled. Patients will be first stratified into two groups: Group A, no prior intra-hepatic arterial treatment; Group B, one prior intra-hepatic arterial treatment).
Primary Outcome
Evaluation of clinical benefit includes status of complete and partial response as well as stable disease
Conditions Studied
Interventions
- DEVICE Sir-Spheres®
Study Locations (1)
Pennsylvania
- Thomas Jefferson University - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2011-10-31 |
| Est. Completion | 2024-12-31 |
| Phase | Phase 2 |
What the finished NCT01473004 record still lists
NCT01473004 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower).
The record links to 1 condition, with Stage IV Uveal Melanoma appearing as the primary indexed condition, and to 1 intervention - of which Sir-Spheres® is the first listed.
NCT01473004 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT01473004 about?
NCT01473004 is a clinical study titled "SIR-Spheres® 90Y Microspheres Treatment of Uveal Melanoma Metastasized to Liver". The purpose of this study is to determine whether radiation provided locally to the liver tumor vasculature environment will demonstrate a response of tumor decline. This radiation may cause the tumor cells to die. This is a phase II clinical trial to investigate safety and efficacy of radioactive ...
What is the current status of trial NCT01473004?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2011-10-31. Estimated completion is 2024-12-31.
What conditions does trial NCT01473004 study?
This clinical trial studies the following conditions: Stage IV Uveal Melanoma.
What interventions are being tested in trial NCT01473004?
The interventions under investigation include: Sir-Spheres® (DEVICE).
Who is sponsoring clinical trial NCT01473004?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01473004 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01473004's enrollment target sits among peer trials
48 1265th of 2000 higher than 718 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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