NCT06084806 · CellSight Technologies, Inc.
Test-retest Evaluation of [18F]F-AraG PET
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
[18F]F-ARAG PET
Two imaging sessions
Primary outcome measures
[18F]F-AraG Test - Re Test
Time frame: 7 days
• Quantitative assessment of tracer uptake by Standardized Uptake Value (SUV) based measurements within volumes of interest on two consecutive \[18F\]F AraG PET scans
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- Serious comorbidities that in the opinion of the investigator/sponsor could compromise protocol objectives.
- Pregnant women or nursing mothers.
- Patients with severe claustrophobia.
Where
- Iowa City, Iowa
Collaborators
University of Iowa
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 24, 2024 · Source of record for eligibility and locations