Lung Cancer Clinical Trial
Fluorine-18-AlphaVBeta6-Binding Peptide Positron Emission Tomography in Metastatic Non-Small Cell Lung Cancer
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.
Full 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
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)
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There is 1 Location for this study
Sacramento California, 95817, United States More Info
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