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NCT00794339 · ClinicalTrials.gov registry record · Phase 2
Phase II Trial of 64Cu-ATSM PET/CT in Cervical Cancer
A Phase 2 study, sponsored by American College of Radiology.
- Terminated
- Registry status
- Phase 2
- Development phase
- 73
- Enrollment target
NCT00794339: Clinical Trial Phase 2 study, sponsored by American College of Radiology.
NCT00794339 is a Phase 2 study that was terminated before completion, run by American College of Radiology. The registered enrollment target is 73 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00794339, a Phase 2 study, was terminated before completion, sponsored by American College of Radiology.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 73 participants
- Enrollment target
Study Summary
RATIONALE: Diagnostic procedures, such as 64Cu-labeled diacetyl-bis\[N4-methylthiosemicarbazone\] (copper Cu 64-ATSM) PET/CT scans, may help doctors predict how patients will respond to treatment. PURPOSE: This phase II trial is studying how well copper Cu 64-ATSM PET/CT scans work in predicting disease progression in patients undergoing standard of care treatment with cisplatin and radiation therapy (external beam and brachytherapy) per National Comprehensive Cancer Network (NCCN) guidelines for newly-diagnosed stage IB, stage II, stage III, or stage IVA cervical cancer via the Federation of Gynecology and Obstetrics (FIGO) staging systems.
Primary Outcome
Progression-free survival (PFS) evaluated every 3 months for first 2 years and every 6 months during year 3 to determine PFS at 3years. Cu64-ATSM Uptake measured within 14 days of baseline Uptake is a measure of activity within a tumor 1. the maximum standardized uptake value (SUVmax = tracer uptake in ROI / (injected activity / patient weight)) 2. Tumor-to-Muscle uptake ratio (T/M, An FDG-PET/CT-guided circular region of interest of 1.0-1.5 cm in diameter is drawn around the most intense regi
Interventions
- DRUG FDG
- DRUG 64Cu-ATSM
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2009-07-29 |
| Est. Completion | 2011-12-31 |
| Phase | Phase 2 |
Why NCT00794339 stopped before completion
NCT00794339 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 73 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (45% lower).
The record links to 0 conditions, and to 2 interventions - of which FDG is the first listed.
NCT00794339 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00794339 about?
NCT00794339 is a clinical study titled "Phase II Trial of 64Cu-ATSM PET/CT in Cervical Cancer". RATIONALE: Diagnostic procedures, such as 64Cu-labeled diacetyl-bis\[N4-methylthiosemicarbazone\] (copper Cu 64-ATSM) PET/CT scans, may help doctors predict how patients will respond to treatment. PURPOSE: This phase II trial is studying how well copper Cu 64-ATSM PET/CT scans work in predicting di...
What is the current status of trial NCT00794339?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 73 participants. The study started on 2009-07-29. Estimated completion is 2011-12-31.
What interventions are being tested in trial NCT00794339?
The interventions under investigation include: FDG (DRUG), 64Cu-ATSM (DRUG).
Who is sponsoring clinical trial NCT00794339?
This trial is sponsored by American College of Radiology, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00794339's enrollment target sits among peer trials
73 924th of 2000 higher than 1,076 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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