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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05452005
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of California, Davis
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Julie L. Sutcliffe, PhD
Principal Investigator Affiliation	The Regents of the University of California (Davis)
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, U.S. Fed
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Lung Cancer, Lung Cancer Metastatic, Brain Metastases, Non Small Cell Lung Cancer

Additional Details

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.

Arms & Interventions

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

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Sacramento, California

Status

Recruiting

Address

The University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817

Site Contact

Julie L Sutcliffe

[email protected]

916-734-5536

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