NCT03520634

PD-L1 PET Imaging in Melanoma Patients

PD-L1 PET Imaging in Patients With an Inoperable Melanoma With Brain Metastasis and Eligible for Treatment With Nivolumab.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University Medical Center Groningen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Melanoma

Interventions

Type	Name	Description
OTHER	PD-L1 PET imaging	PD-L1 PET imaging

Timeline

• Start date: 2017-05-22
• Primary completion: 2021-04-12
• Completion: 2021-04-12
• First posted: 2018-05-11
• Last updated: 2024-05-06

Locations

1 site across 1 country: Netherlands