What this study is
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.
What's being tested
- [18F]-αvβ6-BP
Intervention · DRUG
Subjects will be injected twice with up to 10 millicurie (mCi) of 18F-αvβ6-BP as a rapid intravenous (i.v) bolus.
Study details
- Official title
- Fluorine-18-AlphaVBeta6-Binding Peptide Positron Emission Tomography for Staging, Response Assessment, and Patient Selection in Metastatic Non-Small Cell Lung Cancer
- Sponsor
- University of California, Davis
- Conditions
- Lung Cancer · Lung Cancer Metastatic · Brain Metastases · Non Small Cell Lung Cancer
- Enrolling
- 20 people
- Starts
- 2022-09-13
- Est. completion
- 2025-12-31
- Design
- Open-label, single group, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openThe University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
- Julie L Sutcliffe · Contact916-734-5536jlsutcliffe@ucdavis.edu
- Megan Daly, MD · Sub-investigator
Recruiting
Study team
Sponsor
University of California, Davis
Study ID 1718953
Principal investigator
Julie L. Sutcliffe, PhD
The Regents of the University of California (Davis)
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.