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

  • STATUS
    Recruiting
  • participants needed
    40
  • sponsor
    CellSight Technologies, Inc.
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Updated on 19 February 2024
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Summary

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.

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.

Details
Condition Correlate Tracer Uptake to TCell Tumor Infiltration & CkIT Benefit
Age 18years - 100years
Treatment [18F]F-AraG
Clinical Study IdentifierNCT04260256
SponsorCellSight Technologies, Inc.
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

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
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