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NCT02791594 · ClinicalTrials.gov registry record
Imaging FDG Flare in Melanoma
A clinical trial, sponsored by Abramson Cancer Center at Penn Medicine.
- Completed
- Registry status
- 21
- Enrollment target
NCT02791594: Completed study, sponsored by Abramson Cancer Center at Penn Medicine.
NCT02791594 is a clinical trial that has completed, run by Abramson Cancer Center at Penn Medicine. The registered enrollment target is 21 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02791594 has completed, sponsored by Abramson Cancer Center at Penn Medicine.
- COMPLETED
- Registry status
- 21 participants
- Enrollment target
Study Summary
Up to 35 adult patients with metastatic melanoma planning to start pembrolizumab will be enrolled in this study with a target enrollment of 30 evaluable subjects. Subjects will complete a baseline FDG PET/CT and an on-treatment FDG PET/CT after 1 week of pembrolizumab therapy. Subjects may also be a part of the Penn Melanoma Tissue Collection Program and then will be asked to have one additional tumor biopsy and one additional blood draw for the purposes of this imaging study. Changes in tumor FDG uptake between the baseline and early on-treatment FDG PET/CT scans will be correlated with blood and tissue results from the patient's medical records and from the data collected as part of the Penn Melanoma Tissue Collection Program and with outcomes including objective response, progression free survival, and overall survival.
Primary Outcome
Objective response is defined as the proportion of patients with a complete response or partial response by RECIST version 1.1. A complete response is defined as the disappearance of all tumor lesions, and a decrease in size of all pathological lymph nodes to \<10 mm along the short axis. A partial response is at least a 30% decrease in the sum of diameters of target tumor lesions, taking as reference the baseline sum diameters.
Interventions
- DRUG Pembrolizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2016-06 |
| Est. Completion | 2020-07-01 |
What the finished NCT02791594 record still lists
NCT02791594 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 21 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Pembrolizumab is the first listed.
NCT02791594 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02791594 about?
NCT02791594 is a clinical study titled "Imaging FDG Flare in Melanoma". Up to 35 adult patients with metastatic melanoma planning to start pembrolizumab will be enrolled in this study with a target enrollment of 30 evaluable subjects. Subjects will complete a baseline FDG PET/CT and an on-treatment FDG PET/CT after 1 week of pembrolizumab therapy. Subjects may also be a...
What is the current status of trial NCT02791594?
This trial is currently completed. The enrollment target is 21 participants. The study started on 2016-06. Estimated completion is 2020-07-01.
What interventions are being tested in trial NCT02791594?
The interventions under investigation include: Pembrolizumab (DRUG).
Who is sponsoring clinical trial NCT02791594?
This trial is sponsored by Abramson Cancer Center at Penn Medicine, which has 402 total clinical trials registered on ClinicalTrials.gov.
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