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.
Study sponsor and potential other locations can be found 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
