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

Fluorine-18-AlphaVBeta6-Binding Peptide Positron Emission Tomography for Staging, Response Assessment, and Patient Selection in Metastatic Non-Small Cell Lung Cancer

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.

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:

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)