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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
The University of California Davis Comprehensive Cancer Center
RECRUITING
Sacramento
Contact Information
Primary
Principal Investigator
jlsutcliffe@ucdavis.edu
916-734-5536
Backup
Julie L Sutcliffe
jlsutcliffe@ucdavis.edu
9167345536
Time Frame
Start Date: 2022-09-13
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 20
Treatments
Experimental: 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.
Sponsors
Collaborators: United States Department of Defense
Leads: University of California, Davis

This content was sourced from clinicaltrials.gov