This clinical trial seeks to evaluate an imaging agent, fluorine F 18 alphaVbeta6-binding peptide ([18F]- alphavbeta6-BP), with positron emission tomography/computed tomography (PET/CT) for staging and response assessment in patients with non-small cell lung cancer that has spread to other parts of the body (metastatic). [18F]-alphavbeta6-BP is a radiotracer, which attaches to cancer cells and shines a light that can be seen using a special camera, called a PET scanner. A PET scanner is a camera that takes pictures of the body as it moves through the scanner. The pictures show where the radiotracer is in the body. Using [18F]- alphavbeta6-BP with PET/CT may help doctors diagnose the stage of disease and assess response to treatment in patients receiving standard of care treatment for metastatic non-small cell lung cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT05452005.
Locations matching your search criteria
United States
California
Sacramento
University of California Davis Comprehensive Cancer CenterStatus: Active
Contact: Julie Sutcliffe
Phone: 916-734-5536
PRIMARY OBJECTIVE:
I. To evaluate the sensitivity of fluorine F 18 alphaVbeta6-binding peptide ([18F]- alphavbeta6-BP) PET/CT for detecting non-small cell lung cancer (NSCLC) in alphavbeta6 integrin (+) NSCLC by correlating positive tissue staining from archived tissue for alphavbeta6 integrin by immunohistochemistry (IHC) (using H score of 1+ as a cut-off for positive staining) with [18F]- alphavbeta6-BP PET/CT positivity (defined as standardized uptake value maximum [SUVmax] > background blood pool identified within predefined, measurable tumor deposits identified on standard of care imaging).
SECONDARY OBJECTIVES:
I. To estimate the specificity of [18F]-alphavbeta6-BP PET/CT in imaging NSCLC, in reference to the tissue staining for alphavbeta6 integrin by IHC, in pre-defined measurable sites of disease.
II. To detect known brain metastases (based on standard-of-care magnetic resonance imaging [MRI]) by [18F]- alphavbeta6-BP PET/CT.
III. To correlate SUVmax on [18F]-FDG PET/CT and 18F- alphavbeta6-BP PET/CT on a per lesion basis.
IV. To correlate therapeutic response assessment by standard-of-care MRI brain and [18F]-FDG PET/CT and response assessment by post-treatment [18F]- alphavbeta6-BP PET/CT on a per lesion basis.
OUTLINE:
Patients receive [18F]- alphavbeta6-BP intravenously (IV) and undergo PET/CT over 30 minutes prior to standard of care treatment and then 8-12 weeks after standard of care treatment. Patients undergo collection of blood samples prior to each injection with [18F]- alphavbeta6-BP.
After completion of study, patients are followed up for 12 months.
Lead OrganizationUniversity of California Davis Comprehensive Cancer Center
Principal InvestigatorJulie Sutcliffe
