Test-retest Evaluation of [18F]F-AraG PET
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 nonsmall-cell-lung-cancer
Started Oct 2023
Shorter than P25 for phase_2 nonsmall-cell-lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2023
CompletedFirst Posted
Study publicly available on registry
October 16, 2023
CompletedStudy Start
First participant enrolled
October 31, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2025
CompletedOctober 24, 2024
October 1, 2024
2 years
October 10, 2023
October 22, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
[18F]F-AraG Test - Re Test
• Quantitative assessment of tracer uptake by Standardized Uptake Value (SUV) based measurements within volumes of interest on two consecutive \[18F\]F AraG PET scans
7 days
Study Arms (1)
Advanced non small cell lung cancer (NSCLC) patients
EXPERIMENTALPatients will undergo two \[18F\]F AraG PET/CT scans within 7 days of each other prior to receiving treatment
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- Measurable disease.
- ECOG performance status of 0, 1 or 2.
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
- CellSight Technologies, Inc.lead
- University of Iowacollaborator
Study Sites (1)
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52246, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Muhammad Furqan, M.D.
Holden Comprehensive Cancer Center
Central Study Contacts
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
October 10, 2023
First Posted
October 16, 2023
Study Start
October 31, 2023
Primary Completion
October 31, 2025
Study Completion
October 31, 2025
Last Updated
October 24, 2024
Record last verified: 2024-10