Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2026-02-09 @ 12:06 PM
Study NCT ID:
NCT02791594
Status:
COMPLETED
Last Update Posted:
2024-11-08
First Post:
2016-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Imaging FDG Flare in Melanoma
Sponsor:
Abramson Cancer Center at Penn Medicine
Organization:
Study Overview
Official Title:
Imaging the Flare Response With FDG PET/CT in Patients With Advanced Metastatic Melanoma on Pembrolizumab.
Status:
COMPLETED
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: