Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis
Dates
study started
estimated completion
Principal Investigator
by Julie L. Sutcliffe, PhD (ucdavis)

Description

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.

Official Title

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

Details

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.

Keywords

Lung Cancer, Lung Cancer Metastatic, Brain Metastases, Non Small Cell Lung Cancer, Positron Emission Tomography, Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Brain Neoplasms, [18F]-αvβ6-BP

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Men and women age >18 yrs
  2. Biopsy proven NSCLC with brain metastases (treated or untreated)
  3. Life-expectancy of ≥3 months in the opinion of the treating physician
  4. Available archival tumor tissue (excisional, core, or fine needle aspiration (FNA) is acceptable). Tissue from a metastatic site is preferred when available.
  5. Able to tolerate all study procedures, including remain motionless for up to 30-60 minutes per scan
  6. Ability to understand and willingness to sign a written informed consent document.
  7. Planned to undergo additional cancer-directed therapy followed by standard-of-care re-staging imaging
  8. [18F]-FDG PET/CT within 21 days of enrollment
  9. MRI brain within 21 days of enrollment
  10. . Eastern Cooperative Oncology Group Performance Status ≤ 2
  11. . Glomerular filtration rate (GFR) ≥ 60

You CAN'T join if...

  1. Pregnant or lactating women
  2. Prisoners
  3. Concurrent malignancy of a different histology that could confound imaging interpretation
  4. Patients who cannot undergo PET/CT scanning because of weight limits(>350lbs)

Location

  • The University of California Davis Comprehensive Cancer Center accepting new patients
    Sacramento California 95817 United States

Lead Scientist at UC Cancer

  • Julie L. Sutcliffe, PhD (ucdavis)
    Professor, Hematology and Oncology, School of Medicine. Authored (or co-authored) 61 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Davis
ID
NCT05452005
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 20 study participants
Last Updated