Test-retest Evaluation of [18F]F-AraG PET

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
CellSight Technologies, Inc.
Study ID
NCT06084806
Phase
PHASE2
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • [18F]F-ARAG PET — DRUG
    Two imaging sessions

Study Details

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.

Key Dates

Start date
Oct 31, 2023
Status verified
Oct 2024
Primary completion
Oct 31, 2025
Completion
Oct 31, 2025

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Iowa Hospitals and ClinicsIowa CityIowa52246
Amy Mundisev
319-356-1445

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