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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Lung Cancer, Lung Cancer Metastatic, Brain Metastases, Non Small Cell Lung Cancer

Intervention / Treatment
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* Drug: [18F]-αvβ6-BP


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental [18F]-αvβ6-BP<br>Patients receive [18F]-αvβ6-BP BP IV and then undergo a PET/CT scan over 30 minutes 60 minutes post-injection. | Drug: [18F]-αvβ6-BP<br>* Subjects will be injected twice with up to 10 millicurie (mCi) of 18F-αvβ6-BP as a rapid intravenous (i.v) bolus.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| [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 | Up to six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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. | Up to six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Positron Emission Tomography