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[18F]-αvβ6-BP

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

  • RegistryNCT05452005
  • PhasePhase 1
  • StatusRecruiting
  • ConditionMetastatic Non-Small Cell Lung Cancer
  • SponsorUniversity of California, Davis
How [18F]-αvβ6-BP works1 min

The drug

What is being tested.

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

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.

The study

How the trial runs.

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.

Live record on ClinicalTrials.gov →

Eligibility

Who the study is looking for.

  • 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.

Inclusion criteria as written on the registry, trimmed. The full list, with exclusions, is on the live record.

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