Recruiting
Phase 2

[18F]F-AraG

Sponsor:

CellSight Technologies, Inc.

Code:

NCT06084806

Conditions

Non-small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

[18F]F-ARAG PET

Study Details

Brief summary:

This pilot study aims to evaluate the test-retest variability of \[18F\]F-AraG-PET imaging in patients with advanced NSCLC tumors. The main objectives of the study are to quantify the uptake of \[18F\]F-AraG in tumors and lymphoid tissue in two consecutive scans spaced not longer than 7 days apart from each other to estimate the magnitude of physiologic and measurement variability. To explore these objectives, eligible subjects will undergo two \[18F\]F-AraG PET/CT scans within 7 days of each other prior to receiving treatment. This study is a single-site, open-label, non-randomized, single-arm pilot trial. Patients and care providers will not be blinded to any part of the study.

Conditions

Non-small Cell Lung Cancer

Study ID

NCT06084806

Start date

Oct 31, 2023

Status verified date

Oct, 2024

Completion date

Oct 31, 2025

Anticipated

Primary completion date

Oct 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Patients (>18 years old) with a histologically confirmed NSCLC and a candidate to receive immunotherapy as monotherapy or as combination therapy for advanced/metastatic disease.
2. Measurable disease.
3. ECOG performance status of 0, 1 or 2.

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

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Advanced non small cell lung cancer (NSCLC) patients

Patients will undergo two \[18F\]F AraG PET/CT scans within 7 days of each other prior to receiving treatment

Interventions

[18F]F-ARAG PET

Two imaging sessions

Primary outcome measure

  • [18F]F-AraG Test - Re Test [ Time Frame: 7 days ]

Central Contacts and Locations

Central contacts

Amy Mundisev

319-356-1445amy-mundisev@uiowa.edu

Locations

University of Iowa Hospitals and Clinics

Recruiting

Iowa City, Iowa, United States, 52246

Contacts

Amy Mundisev

319-356-1445amy-mundisev@uiowa.edu

More Information

Sponsor

CellSight Technologies, Inc.

Last update posted

Oct 24, 2024

Last verified

Oct, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by CellSight Technologies, Inc. on 2024-10-24.