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

A Pilot Study of Using [18F]F AraG PET Imaging to Evaluate the Immunological Response to Checkpoint Inhibitor Therapy (CkIT) in Patients With Advanced Solid Tumors

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.

Study Overview

• Status: Terminated
• Conditions: Correlate Tracer Uptake to TCell Tumor Infiltration & CkIT Benefit
• Intervention / Treatment: Drug: [18F]F-AraG

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlate change in [18F]F AraG signal following CkIT therapy with change in level of T cell infiltration in tumor biopsies	Pre and post CkIT biopsies of the same tumor lesion will be performed an analyze T-cell tumor infiltration, this will be correlated to [18F]F-AraG PET signal.	24 Months

Secondary Outcome Measures

Outcome Measure	Time Frame
1. Correlate change in [18F]F AraG uptake signal in tumor lesions with clinical benefit rate (defined as Complete Response (CR) + Partial Response (PR) + stable disease (SD) > 4 months) using iRECIST criteria	24 Months
2. Correlate change in [18F]F AraG signal in lung and GI tract with the occurrence of Grade 3 or 4 immune related adverse events.	24 Months

Collaborators and Investigators

• Sponsor: CellSight Technologies, Inc.
• Collaborators: Oregon Health and Science University; Stanford University
• Investigators: Principal Investigator: Carina Mari Aparici, M.D., Stanford University; Principal Investigator: Erik Mittra, M.D., Oregon Health and Science University; Principal Investigator: Shivaani Kummar, M.D., Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): March 1, 2026
• Study Completion (Actual): March 1, 2026

Study Registration Dates

• First Submitted: February 5, 2020
• First Submitted That Met QC Criteria: February 6, 2020
• First Posted (Actual): February 7, 2020

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 53563

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No