Recruiting
Phase 2

T-Cell Activation

Sponsor:

CellSight Technologies, Inc.

Code:

NCT04726215

Conditions

Non Small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

[18F]F AraG

Study Details

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.

Conditions

Non Small Cell Lung Cancer

Study ID

NCT04726215

Start date

Apr 15, 2021

Status verified date

Sep, 2023

Completion date

Oct 15, 2024

Anticipated

Primary completion date

Oct 15, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Interventions

[18F]F AraG

PET imaging agent specific to activated T cells

Primary outcome measure

  • [18F]F-AraG uptake signal [ Time Frame: two years ]

Central Contacts and Locations

Central contacts

SAMUEL QUEZADA

6507991589squezada@cellsighttech.com

Locations

Palo Alto Veterans Institute of Research

Recruiting

Palo Alto, California, United States, 94304

Contacts

Danny Kwon

800-239-2820DKwon@pavir.org

Nithya Vijayakumar

NVijayakumar@pavir.org

Principal Investigator:

Millie Das, MD

Sutter Cancer Center

Recruiting

Sacramento, California, United States, 95816

Contacts

Michele Guillen Guillen

916-887-4656GuilleM1@sutterhealth.org

Lori Pruski-Clark

916-453-5807

Principal Investigator:

Deepti Behl, MD

Stony Brook University

Recruiting

Stony Brook, New York, United States, 11794

Contacts

Hermina Munoz

631-216-2990Hermina.Munoz@stonybrookmedicine.edu

Principal Investigator:

Roger Keresztes, M.D.

More Information

Sponsor

CellSight Technologies, Inc.

Last update posted

Sep 29, 2023

Last verified

Sep, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by CellSight Technologies, Inc. on 2023-09-29.