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

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.

Inclusion criteria

• Men and women age >18 yrs
• Biopsy proven NSCLC with brain metastases (treated or untreated)
• Life-expectancy of ≥3 months in the opinion of the treating physician
• Available archival tumor tissue (excisional, core, or fine needle aspiration (FNA) is acceptable). Tissue from a metastatic site is preferred when available.
• Able to tolerate all study procedures, including remain motionless for up to 30-60 minutes per scan
• Ability to understand and willingness to sign a written informed consent document.
• Planned to undergo additional cancer-directed therapy followed by standard-of-care re-staging imaging
• [18F]-FDG PET/CT within 21 days of enrollment
• MRI brain within 21 days of enrollment
• Eastern Cooperative Oncology Group Performance Status ≤ 2
• Glomerular filtration rate (GFR) ≥ 60

Exclusion criteria

• Pregnant or lactating women
• Prisoners
• Concurrent malignancy of a different histology that could confound imaging interpretation
• Patients who cannot undergo PET/CT scanning because of weight limits(>350lbs)