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RecruitingNCT04726215Updated Sep 29, 2023

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

A Phase 2 interventional study of [18F]F AraG in Non Small Cell Lung Cancer, sponsored by CellSight Technologies, Inc.. Recruiting at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-29.

Sponsored by CellSight Technologies, Inc. · Phase 2, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Oct 2024, 1 year 11 months ago, but the record still lists the study as recruiting.
  • Started Apr 2021; still recruiting 5 years 5 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Non Small Cell Lung Cancer
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 50 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

CellSight Technologies, Inc. is the lead sponsor of 11 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Interventions

  • Drug[18F]F AraG

    PET imaging agent specific to activated T cells

06

What researchers measure

Primary outcomes

  1. [18F]F-AraG uptake signal

    \[18F\]F-AraG uptake signal will be measured quantitatively by SUV-bw of the tumor volumes of interest before and after undergoing treatment

    Time frame: two years

07

Study locations

3 of 3 sites recruiting
  • Palo Alto Veterans Institute of Research
    Palo Alto, California 94304, United States
    • Danny Kwon · Contact · DKwon@pavir.org · 800-239-2820
    • Nithya Vijayakumar · Contact · NVijayakumar@pavir.org
    • Millie Das, MD · Principal investigator
    • Minal s Vasanawala, MD · Principal investigator
    Recruiting
  • Sutter Cancer Center
    Sacramento, California 95816, United States
    • Michele Guillen Guillen · Contact · GuilleM1@sutterhealth.org · 916-887-4656
    • Lori Pruski-Clark · Contact · 916-453-5807
    • Deepti Behl, MD · Principal investigator
    Recruiting
  • Stony Brook University
    Stony Brook, New York 11794, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04726215
Lead sponsor
CellSight Technologies, Inc.
Responsible party
Sponsor
First posted
Jan 27, 2021
Start date
Apr 15, 2021
Primary completion
Oct 15, 2024 (estimated)
Completion
Oct 15, 2024 (estimated)
Last update
Sep 29, 2023

Study contacts

SAMUEL QUEZADA
Contact
squezada@cellsighttech.com
6507991589
Deepak Behera, MD
principal investigator · CellSight Technologies, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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