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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 is a Phase 1 study that was terminated before completion, run by Washington University School of Medicine. The registered enrollment target is 4 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02891616
The ClinicalTrials.gov registry entry for NCT02891616 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which fludeoxyglucose F 18 is the first listed.
NCT02891616 reports 0 study locations.
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.
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