Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2025-12-26 @ 12:50 AM
Study NCT ID:
NCT03520634
Status:
COMPLETED
Last Update Posted:
2024-05-06
First Post:
2016-05-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PD-L1 PET Imaging in Melanoma Patients
Sponsor:
University Medical Center Groningen
Organization:
Study Overview
Official Title:
PD-L1 PET Imaging in Patients With an Inoperable Melanoma With Brain Metastasis and Eligible for Treatment With Nivolumab.
Status:
COMPLETED
Status Verified Date:
2021-04
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:
This is a feasibility study for the use of \[18F\]PD-L1 as a PET tracer that will be conducted in a single center. The study consists of two phases. The aim of phase one is to provide pharmacokinetic information on the tracer and to determine the optimal time point for imaging. In the second phase the main study objective will be assessed.
Detailed Description:
This is a single center feasibility study for the application of \[18F\]PD-L1 PET in patients with metastatic melanoma and NSCLC treated with anti-PD-1 therapy. The study will consist of a pharmacokinetics phase (phase one) and tracer validation phase (phase two). Phase one will be performed in a maximum of 5 patients. A \[18F\]PD-L1 PET scan will be performed at baseline and six weeks after treatment initiation. Upon finishing phase one, the optimal time for tracer injection will bedetermined prior to the start of phase two. In phase two a \[18F\]PD-L1 PET-CT scan will be performed in 10 patients at baseline and six weeks after treatment initiation. Also, when it is feasible a biopsy will be taken from at least one accessible tumor location after the PET-scan at baseline and the PET-scan after six weeks of therapy.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: