NCT04726215

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2021

Typical duration for phase_2

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 27, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

April 15, 2021

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2024

Completed
Last Updated

September 29, 2023

Status Verified

September 1, 2023

Enrollment Period

3.5 years

First QC Date

January 21, 2021

Last Update Submit

September 27, 2023

Conditions

Non Small Cell Lung Cancer

Outcome Measures

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

    two years

Interventions

[18F]F AraGDRUG

PET imaging agent specific to activated T cells

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Serious comorbidities that in the opinion of the investigator/sponsor could compromise protocol objectives.
  • Pregnant women or nursing mothers.
  • Patients with severe claustrophobia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Palo Alto Veterans Institute of Research

Palo Alto, California, 94304, United States

RECRUITING

Sutter Cancer Center

Sacramento, California, 95816, United States

RECRUITING

Stony Brook University

Stony Brook, New York, 11794, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Deepak Behera, MD

    CellSight Technologies, Inc.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

SAMUEL QUEZADA

CONTACT

6507991589squezada@cellsighttech.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2021

First Posted

January 27, 2021

Study Start

April 15, 2021

Primary Completion

October 15, 2024

Study Completion

October 15, 2024

Last Updated

September 29, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

US(3)