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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04260256

Enrollment

Registered

2020-02-07

Start date

2022-03-01

Completion date

2026-03-01

Last updated

2026-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Correlate Tracer Uptake to TCell Tumor Infiltration & CkIT Benefit

Brief 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.

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.

Interventions

DRUG[18F]F-AraG

\[18F\]F AraG injection and PET Scan Two tumor biopsies of single lesion

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Correlate change in [18F]F AraG signal following CkIT therapy with change in level of T cell infiltration in tumor biopsies	24 Months	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.

Secondary

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

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORCarina Mari Aparici, M.D.

Stanford University

PRINCIPAL_INVESTIGATORErik Mittra, M.D.

Oregon Health and Science University

PRINCIPAL_INVESTIGATORShivaani Kummar, M.D.