RecruitingPhase 1NCT05452005

Fluorine-18-AlphaVBeta6-Binding Peptide Positron Emission Tomography in Metastatic Non-Small Cell Lung Cancer

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

Enrollment

20 participants

Start Date

Sep 13, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria11

  • 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 Criteria4

  • 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)

Interventions

DRUG[18F]-αvβ6-BP

Subjects will be injected twice with up to 10 millicurie (mCi) of 18F-αvβ6-BP as a rapid intravenous (i.v) bolus.


Locations(1)

The University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05452005


Related Trials