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

NCT ID: NCT04260256

Last Updated: 2025-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2026-11-30

Brief Summary

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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

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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.

Conditions

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Correlate Tracer Uptake to TCell Tumor Infiltration & CkIT Benefit

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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[18F]F-AraG

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

Intervention Type DRUG

Other Intervention Names

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VisAcT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role collaborator

Oregon Health and Science University

OTHER

Sponsor Role collaborator

CellSight Technologies, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carina Mari Aparici, M.D.

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Erik Mittra, M.D.

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Shivaani Kummar, M.D.

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

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Stanford University

Stanford, California, United States

Site Status RECRUITING

Oregon Health and Science University

Portland, Oregon, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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LIbby Mirande

Role: CONTACT

503 494 4740

Facility Contacts

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Kavin Tamizhmani

Role: primary

650-497-6046

Libby Mirande

Role: primary

503-494-4740

Other Identifiers

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53563

Identifier Type: -

Identifier Source: org_study_id

NCT05219981

Identifier Type: -

Identifier Source: nct_alias

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