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NCT05452005PHASE1Recruiting

Fluorine-18-AlphaVBeta6-Binding Peptide Positron Emission Tomography in Metastatic Non-Small Cell Lung Cancer

University of California, Davis

Start Date

9/13/2022

Completion Date

12/31/2026

Summary

This study investigates fluorine-18-AlphaVBeta6-BP (\[18F\]-αvβ6-BP) as a Positron Emission (PET) imaging agent in Non-Small Cell Lung Cancer (NSCLC) patients with brain metastases. Investigators hypothesize that \[18F\]-αvβ6-BP PET/Computed Tomography (CT) is a sensitive tool for disease assessment in patients with metastatic NSCLC, including those with brain metastases.

Detailed Description

PRIMARY OBJECTIVE: The primary objective of this study is to evaluate the sensitivity and specificity of \[18F\]-αvβ6-BP PET/CT for detecting metastases in patients with NSCLC. OUTLINE: Patients will undergo \[18F\]-αvβ6-BP PET/CT at baseline in addition to standard-of-care \[18F\]-2-fluoro-2-deoxy-D-glucose (FDG) PET/CT body and magnetic resonance imaging (MRI) of the brain. Patients will then undergo standard-of-care cancer directed therapy. Patients will be re-staged 8-12 weeks later at the next standard-of-care imaging time point with \[18F\]-αvβ6-BP PET/CT, \[18F\]-FDG PET/CT, and MRI.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: 1. Men and women age \>18 yrs 2. Biopsy proven NSCLC with brain metastases (treated or untreated) 3. Life-expectancy of ≥3 months in the opinion of the treating physician 4. Available archival tumor tissue (excisional, core, or fine needle aspiration (FNA) is acceptable). Tissue from a metastatic site is preferred when available. 5. Able to tolerate all study procedures, including remain motionless for up to 30-60 minutes per scan 6. Ability to understand and willingness to sign a written informed consent document. 7. Planned to undergo additional cancer-directed therapy followed by standard-of-care re-staging imaging 8. \[18F\]-FDG PET/CT within 21 days of enrollment 9. MRI brain within 21 days of enrollment 10. Eastern Cooperative Oncology Group Performance Status ≤ 2 11. Glomerular filtration rate (GFR) ≥ 60 Exclusion Criteria: 1. Pregnant or lactating women 2. Prisoners 3. Concurrent malignancy of a different histology that could confound imaging interpretation 4. Patients who cannot undergo PET/CT scanning because of weight limits(\>350lbs)

Interventions

DRUG

[18F]-αvβ6-BP

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Conditions

Lung CancerLung Cancer MetastaticBrain MetastasesNon Small Cell Lung Cancer

Locations

The University of California Davis Comprehensive Cancer Center

Sacramento, California 95817

United States