Imaging of T-cell Activation With [18F]F-AraG in Advanced Non Small Cell Lung Cancer

September 27, 2023 updated by: CellSight Technologies, Inc.

Imaging of T-cell Activation With [18F]F-AraG in Advanced Non Small Cell Lung Cancer (NSCLC) Patients Undergoing PD-1/PD-L1 Directed Therapy

This is a pilot study using [18F]F AraG PET imaging to evaluate the immunological response to checkpoint inhibitor therapy (CkIT) in patients with advanced NSCLC tumors at multiple study sites. The main objectives of the study are to quantify the change in [18F]F AraG PET signal before and after CkIT therapy, and to correlate this change in [18F]F AraG PET signal with a radiographic response.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Approximately 50 patients will undergo two research PET/CT scans with [18F]F AraG at two time points. Each patient will receive two 5 (+/-10%) mCi doses of [18F]F AraG, one for each imaging time point. Eligible subjects will undergo a pre-treatment [18F]F AraG PET/CT scan within 7 days prior to treatment, followed by treatment, and an on-treatment [18F]F AraG PET/CT within 7-14 days of treatment.

Objectives:

  • Quantify [18F]F-AraG uptake in advanced NSCLC tumor (primary, nodal, and metastatic sites) at baseline and after 1 dose of anti-PD-1/PD-L1 therapy in patients treated with standard of care immunotherapy (as monotherapy or part of combination therapy).
  • Correlate change in [18F]F AraG uptake in tumor lesions with radiographic response.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Palo Alto Veterans Institute of Research
        • Contact:
        • Contact:
        • Principal Investigator:
          • Millie Das, MD
        • Principal Investigator:
          • Minal s Vasanawala, MD
      • Sacramento, California, United States, 95816
        • Recruiting
        • Sutter Cancer center
        • Contact:
        • Contact:
          • Lori Pruski-Clark
          • Phone Number: 916-453-5807
        • Principal Investigator:
          • Deepti Behl, MD
    • New York
      • Stony Brook, New York, United States, 11794

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients with a histologically confirmed NSCLC and planned to undergo immunotherapy as monotherapy or as combination therapy with concurrent as treatment for advanced/metastatic disease.
  2. RECIST measurable disease.
  3. ECOG performance status of 0, 1 or 2.
  4. Life expectancy >/= 6 months at enrollment.

Exclusion Criteria:

  1. Serious comorbidities that in the opinion of the investigator/sponsor could compromise protocol objectives.
  2. Pregnant women or nursing mothers.
  3. Patients with severe claustrophobia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
[18F]F-AraG uptake signal
Time Frame: two years
[18F]F-AraG uptake signal will be measured quantitatively by SUV-bw of the tumor volumes of interest before and after undergoing treatment
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CellSight Technologies, Inc.

Investigators

  • Principal Investigator: Deepak Behera, MD, CellSight Technologies, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2021

Primary Completion (Estimated)

October 15, 2024

Study Completion (Estimated)

October 15, 2024

Study Registration Dates

First Submitted

January 21, 2021

First Submitted That Met QC Criteria

January 22, 2021

First Posted (Actual)

January 27, 2021

Study Record Updates

Last Update Posted (Actual)

September 29, 2023

Last Update Submitted That Met QC Criteria

September 27, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CST-FARAG-IO-MULT-201

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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