Imaging of T-cell Activation With [18F]F-AraG in Advanced Non Small Cell Lung Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04726215|
Recruitment Status : Recruiting
First Posted : January 27, 2021
Last Update Posted : April 13, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Non Small Cell Lung Cancer||Drug: [18F]F AraG||Phase 2|
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.
- 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 (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||April 15, 2021|
|Estimated Primary Completion Date :||April 15, 2023|
|Estimated Study Completion Date :||May 15, 2023|
- Drug: [18F]F AraG
PET imaging agent specific to activated T cells
- [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
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- RECIST measurable disease.
- ECOG performance status of 0, 1 or 2.
- Life expectancy >/= 6 months at enrollment.
- Serious comorbidities that in the opinion of the investigator/sponsor could compromise protocol objectives.
- Pregnant women or nursing mothers.
- Patients with severe claustrophobia.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04726215
|Contact: SAMUEL QUEZADAemail@example.com|
|United States, California|
|Palo Alto Veterans Institute of Research||Recruiting|
|Palo Alto, California, United States, 94304|
|Contact: Danny Kwon 800-239-2820 DKwon@pavir.org|
|Contact: Nithya Vijayakumar NVijayakumar@pavir.org|
|Principal Investigator: Millie Das, MD|
|Principal Investigator: Minal s Vasanawala, MD|
|Sutter Cancer Center||Recruiting|
|Sacramento, California, United States, 95816|
|Contact: Michele Guillen Guillen 916-887-4656 GuilleM1@sutterhealth.org|
|Contact: Lori Pruski-Clark 916-453-5807|
|Principal Investigator: Deepti Behl, MD|
|United States, New York|
|Stony Brook University||Recruiting|
|Stony Brook, New York, United States, 11794|
|Contact: Hermina Munoz 631-216-2990 Hermina.Munoz@stonybrookmedicine.edu|
|Principal Investigator: Roger Keresztes, M.D.|
|Principal Investigator:||Deepak Behera, MD||CellSight Technologies, Inc.|
|Responsible Party:||CellSight Technologies, Inc.|
|Other Study ID Numbers:||
|First Posted:||January 27, 2021 Key Record Dates|
|Last Update Posted:||April 13, 2022|
|Last Verified:||April 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases