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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
20
Subjects will be injected twice with up to 10 millicurie (mCi) of 18F-αvβ6-BP as a rapid intravenous (i.v) bolus.
The University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
RECRUITING[18F]-αvβ6-BP PET/CT imaging compared to immunohistochemistry
Standard uptake value (SUV) values from \[18F\]-αvβ6-BP PET/CT will be compared to immunohistochemistry (IHC) αvβ6 staining of archival tissue to assess the sensitivity of \[18F\]-αvβ6-BP PET/CT to detect αvβ6 positive metastasis in NSCLC
Time frame: Up to six months
Comparison of standard-of-care MRI and [18F]-αvβ6-BP PET/CT imaging
Detection of lesions with \[18F\]-αvβ6-BP will be compared to the number of lesions identified during standard-of-care MRI imaging
Time frame: Up to six months
Comparison of standard-of-care [18F]-FDG PET/CT and [18F]-αvβ6-BP PET/CT imaging
SUVmax values obtained during standard-of-care FDG/PET will be compared to SUVmax values obtained from \[18F\]-αvβ6-BP PET/CT imaging
Time frame: Up to six months
Comparison of standard-of-care MRI brain and [18F]-FDG PET/CT and [18F]-αvβ6-BP PET/CT imaging post treatment
Lesion response will be assessed based on standard-of-care MRI images, \[18F\]-FDG PET/CT and \[18F\]-αvβ6-BP PET/CT post treatment.
Time frame: Up to six months
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