Fluorine-18-AlphaVBeta6-Binding Peptide Positron Emission Tomography in Metastatic Non-Small Cell Lung Cancer
Recruiting · NCT05452005 · Interventional (participants receive a specific treatment) · Lead sponsor: University of California, Davis
View the official record on ClinicalTrials.gov →Interventions studied
[18F]-αvβ6-BP
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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)
Where it is running
1 location listed across 1 US state.
- The University of California Davis Comprehensive Cancer Center - Sacramento, California, United States