A Study Using [18F]F AraG PET to Evaluate Response to Checkpoint Inhibitor Therapy(CkIT) in Patients With Solid Tumors

CellSight Technologies

Status and phase: Enrolling; Phase 2

Conditions: Correlate Tracer Uptake to TCell Tumor Infiltration & CkIT Benefit

Treatments: Drug: [18F]F-AraG

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04260256

53563

Details and patient eligibility

About

In this study, patients with advanced solid tumors will undergo [18F]F AraG PET/CT imaging to assess for changes in tracer uptake following treatment with CkIT.

Full description

Up to 40 patients will be recruited to participate in this study. Two (2) target lesions per patient will be selected for radiomics and biopsy. Both lesions will be assessed for [18F]F AraG uptake before and after CkIT. Only one lesion will be biopsied twice (once before and once after CkIT treatment close to the time of imaging), and the other lesion will not be manipulated and used as a control.

There will be a pre therapy scan [18F]F AraG which will be administered anytime within a 14 day period prior to the initial Day 1 CkIT administration. There will also be a post therapy scan which will be performed within 3 to 6 weeks after the initial CkIT dose. The timing of the second [18F]F AraG scans may be altered based on preliminary results from the initial patient scan results, and could be obtained during the first 2 weeks after initiation of therapy.

The investigators will compare the [18F]F AraG activity (based on development of tumoral volumes of interest (VOIs) pre and post CkIT in both lesions.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Solid tumor with planned CkIT
• Must be >18 years old
• Signed Informed Consent Form
• Patient must have two qualifying lesions

Exclusion criteria

• Patient is pregnant or breast feeding

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)