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

University of California (UC) Davis

Status and phase: Enrolling; Phase 1

Conditions: Lung Cancer Metastatic; Brain Metastases; Lung Cancer; Non Small Cell Lung Cancer

Treatments: Drug: [18F]-αvβ6-BP

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05452005

1718953

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 30-60 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

Exclusion criteria

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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Experimental [18F]-αvβ6-BP

Experimental group

Description:

Patients receive \[18F\]-αvβ6-BP BP IV and then undergo a PET/CT scan over 30 minutes 60 minutes post-injection.

Treatment:

Drug: [18F]-αvβ6-BP