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A Study of PET 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 prospective, single center, single-arm clinical trial in 20 patients with non-small cell lung cancer (NSCLC) undergoing PD-1/PD-L1-directed therapy. This research is being done to find out if the radioactive compound called \[18F\]F-AraG is a helpful imaging agent for detecting changes in cancer's anti-tumor immune response (or activation of T-cell) levels for non-small cell lung cancer (NSCLC) patients who will receive a cancer immunotherapy regimen (immunotherapy works by encouraging the body's own immune system to attack the cancer cells).
The purpose of this study is to find out how the radiotracer called \[18F\]F-AraG can help investigate changes in cancer's anti-tumor immune response (or activation of T-cell) levels during positron emission tomography (PET) scans. \[18F\]F-AraG has the potential to serve as a noninvasive imaging biomarker in the monitoring of T-cell mediated anti-tumor immune response following administration of an immunotherapeutic agent. Participants in this study will have tests, exams and procedures that are for study purposes. Participants will be in this study up to one month which will include about three clinic visits. A baseline \[18F\]F-AraG PET-CT will be obtained 0-7 days before a NSCLC patient receives PD-1/PD-L1 immunotherapy. A second \[18F\]F-AraG PET-CT will be performed 10-14 days after PD-1/PD-L1 immunotherapy is administered.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Johns Hopkins University
Baltimore, Maryland, United States
Start Date
February 1, 2021
Primary Completion Date
November 27, 2023
Completion Date
November 27, 2023
Last Updated
January 17, 2024
4
ACTUAL participants
[18F]F-AraG Injection
DRUG
Lead Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
NCT06305754
NCT05920356
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06128551