Fluorine-18-AlphaVBeta6-Binding Peptide Positron Emission Tomography for Staging, Response Assessment, and Patient Selection in Metastatic Non-Small Cell Lung Cancer
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- [18F]-αvβ6-BP PET/CT imaging compared to immunohistochemistry
Study Overview
Brief 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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Concurrent malignancy of a different histology that could confound imaging interpretation
- •Patients who cannot undergo PET/CT scanning because of weight limits(>350lbs)
Arms & Interventions
Experimental [18F]-αvβ6-BP
Patients receive [18F]-αvβ6-BP BP IV and then undergo a PET/CT scan over 30 minutes 60 minutes post-injection.
Intervention: [18F]-αvβ6-BP (Drug)
Outcomes
Primary Outcomes
[18F]-αvβ6-BP PET/CT imaging compared to immunohistochemistry
Time Frame: Up to six months
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
Secondary Outcomes
- Comparison of standard-of-care MRI brain and [18F]-FDG PET/CT and [18F]-αvβ6-BP PET/CT imaging post treatment(Up to six months)
- Comparison of standard-of-care [18F]-FDG PET/CT and [18F]-αvβ6-BP PET/CT imaging(Up to six months)
- Comparison of standard-of-care MRI and [18F]-αvβ6-BP PET/CT imaging(Up to six months)
Investigators
Julie L. Sutcliffe, Ph.D
Professor of Internal Medicine and Biomedical Engineering
University of California, Davis