PD-L1 PET Imaging in Melanoma Patients

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Melanoma

Clinical Trial Details

NCT number	NCT03520634
Study type	Interventional
Source	University Medical Center Groningen
Contact
Status	Completed
Phase	N/A
Start date	May 22, 2017
Completion date	April 12, 2021

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