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NCT02891616 · ClinicalTrials.gov registry record · Phase 1
18F-FLT PET Imaging in Patients With Advanced Melanoma
A Phase 1 study, sponsored by Washington University School of Medicine.
- Terminated
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
NCT02891616: Clinical Trial Phase 1 study, sponsored by Washington University School of Medicine.
NCT02891616 is a Phase 1 study that was terminated before completion, run by Washington University School of Medicine. The registered enrollment target is 4 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02891616, a Phase 1 study, was terminated before completion, sponsored by Washington University School of Medicine.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
Study Summary
In the current study, advanced positron emission tomography/computed tomography (PET/CT) and positron emission tomography/magnetic resonance (PET/MR) imaging methods will be used to validate our hypothesis that melanoma patients receiving Dual-Immune Checkpoint Blockade (DICB) therapy, who ultimately achieve clinical benefit, will have an increase, or "FLARE", in tumor FLT and/or FDG uptake from baseline, as seen after cycle#1 of treatment, and that after 2 cycles of treatment responders will have a decline in FLT and FDG uptake, in comparison to the patients classified as "non-responders". In addition, alterations in tumor apparent diffusion coefficient (ADC) on diffusion-weighted magnetic resonance imaging (DW/MRI) will be evaluated, expecting after cycle#1: transient reductions in ADC due to lymphocyte proliferation, increased cellularity and restriction of water movement in responding patients, with these patients tumors having increased ADC at 2 cycles into therapy associated with tumor necrosis. This study will evaluate rather early PET imaging with FLT and FDG is a useful imaging biomarker of response to DICB.
Interventions
- DRUG fludeoxyglucose F 18
- DEVICE Positron emission tomography-computed tomography
- DRUG 18F-fluorothymidine
- DEVICE Positron emission tomography-magnetic resonance imaging
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2016-10-10 |
| Est. Completion | 2017-12-31 |
| Phase | Phase 1 |
Why NCT02891616 stopped before completion
NCT02891616 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 4 interventions - of which fludeoxyglucose F 18 is the first listed.
NCT02891616 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02891616 about?
NCT02891616 is a clinical study titled "18F-FLT PET Imaging in Patients With Advanced Melanoma". In the current study, advanced positron emission tomography/computed tomography (PET/CT) and positron emission tomography/magnetic resonance (PET/MR) imaging methods will be used to validate our hypothesis that melanoma patients receiving Dual-Immune Checkpoint Blockade (DICB) therapy, who ultimatel...
What is the current status of trial NCT02891616?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2016-10-10. Estimated completion is 2017-12-31.
What interventions are being tested in trial NCT02891616?
The interventions under investigation include: fludeoxyglucose F 18 (DRUG), Positron emission tomography-computed tomography (DEVICE), 18F-fluorothymidine (DRUG), Positron emission tomography-magnetic resonance imaging (DEVICE).
Who is sponsoring clinical trial NCT02891616?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02891616's enrollment target sits among peer trials
4 1995th of 2000 higher than 2 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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