Test-retest Evaluation of [18F]F-AraG PET
Test-retest Evaluation of [18F]F-AraG PET in Non-small Cell Lung Cancer (NSCLC) Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Checkpoint inhibitor therapy has led to impressive clinical successes, providing objective and durable responses in patients with advanced cancers that previously had very few treatment options. Unfortunately, immunotherapy works only in a relatively small fraction of patients with solid tumors.
The current standard of care anatomic imaging adequately assessed treatment efficacy in the pre-immunotherapy era, when tumor volume burden directly correlated with clinical outcomes. However, anatomic imaging is found to be limited due to the cellular and molecular nature of early responses to immunotherapy. PET imaging is a sensitive technique that uses radiolabeled agents to visualize the distribution of specific molecular targets in the body. Based on its ability to pinpoint molecular activity, PET imaging agents that target key players of the immune response could offer a powerful noninvasive tool for evaluation of complex immunologic processes within the body.
[18F]F-AraG was developed as an agent for imaging activated T cells (Namavari et al., 2011)). [18F]F-AraG is a 18F-labeled analog of 9-b-D-Arabinofuranosylguanine a compound that has shown selective accumulation in T cells (Eriksson, et al., 1994) and whose prodrug, nelarabine, is FDA-approved for treatment of patients with T cell acute lymphoblastic leukemia and T cell lymphoblastic lymphoma. [18F]F-AraG is independent of the type of immunotherapy regimen being administered adoptive cell therapy, checkpoint inhibitors, cancer vaccines or a combination of immunotherapy and conventional medicines. In vivo, real time imaging of activated T cells in solid tumors before and at a timepoint during and after CkIT therapy can help understand the effects of checkpoint blockade therapy. Repeatability, as an estimate of the magnitude of change that distinguishes normal physiologic and measurement variability from true biologic change, is important to interpreting changes encountered on PET scans in the response-to-treatment setting.
This study will establish test-retest variability of [18F]F-AraG uptake in tumors (primary and metastatic sites) and lymphoid tissue in NSCLC patients prior to start of therapy. The results lead to a better understanding of the parameters affecting signal quantitation.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Amy Mundisev
- Phone Number: 319-356-1445
- Email: amy-mundisev@uiowa.edu
Study Locations
-
-
Iowa
-
Iowa City, Iowa, United States, 52246
- Recruiting
- University of Iowa Hospitals and Clinics
-
Contact:
- Amy Mundisev
- Phone Number: 319-356-1445
- Email: amy-mundisev@uiowa.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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
|
Two imaging sessions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
[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
|
7 days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Muhammad Furqan, M.D., Holden Comprehensive Cancer Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CST-FARAG-IO-UIOW-201-TRT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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