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

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ClinicalTrials.gov Identifier: NCT04726215
Recruitment Status : Recruiting
First Posted : January 27, 2021
Last Update Posted : April 13, 2022
Sponsor:
Information provided by (Responsible Party):
CellSight Technologies, Inc.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Drug: [18F]F AraG Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Intervention Details:
  • Drug: [18F]F AraG
    PET imaging agent specific to activated T cells

Outcome Measures
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Primary Outcome Measures :
  1. [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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: SAMUEL QUEZADA 6507991589 squezada@cellsighttech.com

Locations
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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.         
Sponsors and Collaborators
CellSight Technologies, Inc.
Investigators
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Principal Investigator: Deepak Behera, MD CellSight Technologies, Inc.
More Information
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Responsible Party: CellSight Technologies, Inc.
ClinicalTrials.gov Identifier: NCT04726215    
Other Study ID Numbers: CST-FARAG-IO-MULT-201
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms