Fluorine-18-AlphaVBeta6-Binding Peptide Positron Emission Tomography in Metastatic Non-Small Cell Lung Cancer
- Conditions
- Non Small Cell Lung CancerBrain MetastasesLung CancerLung Cancer Metastatic
- Interventions
- Drug: [18F]-αvβ6-BP
- Registration Number
- NCT05452005
- Lead Sponsor
- University of California, Davis
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Experimental [18F]-αvβ6-BP [18F]-αvβ6-BP Patients receive \[18F\]-αvβ6-BP BP IV and then undergo a PET/CT scan over 30 minutes 60 minutes post-injection.
- Primary Outcome Measures
Name Time Method [18F]-αvβ6-BP PET/CT imaging compared to immunohistochemistry 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 Outcome Measures
Name Time Method 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 Lesion response will be assessed based on standard-of-care MRI images, \[18F\]-FDG PET/CT and \[18F\]-αvβ6-BP PET/CT post treatment.
Comparison of standard-of-care [18F]-FDG PET/CT and [18F]-αvβ6-BP PET/CT imaging Up to six months SUVmax values obtained during standard-of-care FDG/PET will be compared to SUVmax values obtained from \[18F\]-αvβ6-BP PET/CT imaging
Comparison of standard-of-care MRI and [18F]-αvβ6-BP PET/CT imaging Up to six months Detection of lesions with \[18F\]-αvβ6-BP will be compared to the number of lesions identified during standard-of-care MRI imaging
Trial Locations
- Locations (1)
The University of California Davis Comprehensive Cancer Center
🇺🇸Sacramento, California, United States