Recruiting
Phase 1

Fluorine-18-AlphaVBeta6-Binding Peptide

Sponsor:

UCLA

Code:

NCT05452005

Conditions

Lung Cancer

Lung Cancer Metastatic

Brain Metastases

Non Small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

[18F]-αvβ6-BP

Study Details

Brief 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.

Conditions

Lung Cancer

Lung Cancer Metastatic

Brain Metastases

Non Small Cell Lung Cancer

Study ID

NCT05452005

Start date

Sep 13, 2022

Status verified date

Feb, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Experimental [18F]-αvβ6-BP

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

Interventions

[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.

Primary outcome measure

  • [18F]-αvβ6-BP PET/CT imaging compared to immunohistochemistry [ Time Frame: Up to six months ]

Central Contacts and Locations

Central contacts

Principal Investigator

916-734-5536jlsutcliffe@ucdavis.edu

Julie L Sutcliffe

9167345536jlsutcliffe@ucdavis.edu

Locations

The University of California Davis Comprehensive Cancer Center

Recruiting

Sacramento, California, United States, 95817

Contacts

Julie L Sutcliffe

916-734-5536jlsutcliffe@ucdavis.edu

More Information

Sponsor

University of California, Davis

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Keywords

  • Positron Emission Tomography

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Davis on 2026-02-27.