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Recruiting Phase 1 NCT05452005

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

Trial Parameters

Condition Lung Cancer
Sponsor University of California, Davis
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 20
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2022-09-13
Completion 2026-12-31
Interventions
[18F]-αvβ6-BP

Brief 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.

Eligibility Criteria

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

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