NCT05452005 · University of California, Davis
Fluorine-18-AlphaVBeta6-Binding Peptide Positron Emission Tomography in Metastatic Non-Small Cell Lung Cancer
What this study is 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.
View original scientific description
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.
Interventions
DRUG
[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 measures
[18F]-αvβ6-BP PET/CT imaging compared to immunohistochemistry
Time frame: Up to six months
Standard uptake value (SUV) values from \[18F\]-αvβ6-BP PET/CT will be compared to immunohistochemistry (IHC) αvβ6 staining of archival tissue to assess the sensitivity of \[18F\]-αvβ6-BP PET/CT to detect αvβ6 positive metastasis in NSCLC
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
- Planned to undergo additional cancer-directed therapy followed by standard-of-care re-staging imaging
- \[18F\]-FDG PET/CT within 21 days of enrollment
- MRI brain within 21 days of enrollment
- Eastern Cooperative Oncology Group Performance Status ≤ 2
- Glomerular filtration rate (GFR) ≥ 60
Exclusion criteria
- Pregnant or lactating women
- Concurrent malignancy of a different histology that could confound imaging interpretation
- Patients who cannot undergo PET/CT scanning because of weight limits(\>350lbs)
Where
- Sacramento, California
Collaborators
United States Department of Defense
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 27, 2026 · Source of record for eligibility and locations