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

• Status: Recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Davis
• Collaborator: United States Department of Defense

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

4. Patients who cannot undergo PET/CT scanning because of weight limits(>350lbs)