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

Last updated: December 3, 2024
Sponsor: University of California, Davis
Overall Status: Active - Recruiting

Phase

1

Condition

Cancer

Brain Metastases

Non-small Cell Lung Cancer

Treatment

[18F]-αvβ6-BP

Clinical Study ID

NCT05452005
1718953
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  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 30-60minutes 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-carere-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

Exclusion

Exclusion Criteria:

  1. Pregnant or lactating women

  2. Prisoners

  3. Concurrent malignancy of a different histology that could confound imaginginterpretation

  4. Patients who cannot undergo PET/CT scanning because of weight limits(>350lbs)

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: [18F]-αvβ6-BP
Phase: 1
Study Start date:
September 13, 2022
Estimated Completion Date:
December 31, 2025

Study Description

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.

Connect with a study center

  • The University of California Davis Comprehensive Cancer Center

    Sacramento, California 95817
    United States

    Active - Recruiting

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