This phase I trial tests the safety, side effects and effectiveness of [68Ga]Ga DOTA-5G as a diagnostic imaging agent for patients with invasive lobular breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). [68Ga]Ga DOTA-5G binds to receptors expressed by certain types of tumor cells and emits radioactivity that can then be detected by positron emission tomography (PET). A PET scan is a procedure in which a small amount of tracer (in this case [68Ga]Ga DOTA-5G) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the tracer is taken up. Computed tomography (CT) is a procedure that uses a computer linked to an x-ray machine to make a series of detailed pictures of areas inside the body. The pictures are taken from different angles and are used to create 3-dimensional views of tissues and organs. Combining a PET scan with a CT scan can help make the image easier to interpret. PET/CT scans are hybrid scanners that combine both modalities into a single scan during the same examination. Using [68Ga]Ga DOTA-5G as a diagnostic imaging agent with PET/CT may be safe and effective in diagnosing patients with metastatic or advanced invasive lobular breast cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT07020806.
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 OBJECTIVES:
I. To assess the ability of gallium Ga 68-DOTA-5G ([68Ga]Ga DOTA-5G) to detect lesions: detection of metastasis by [68Ga]Ga DOTA-5G, positive versus (vs.) negative based on if standard update value maximum (SUVmax) > 2-fold above normal brain, bone, lung, or liver of [68Ga]Ga DOTA-5G in at least one lesion assessed by [68Ga]Ga DOTA-5G PET/CT and identified on [18F]-fludeoxyglucose (FDG) PET/CT diagnostic imaging.
II. To evaluate the safety and tolerability of [68Ga]Ga DOTA-5G: incidence of adverse events using Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).
SECONDARY OBJECTIVES:
I. To compare SUVmax on [68Ga]Ga DOTA-5G PET/CT and [18F]-FDG PET/CT and on a per lesion basis.
II. To compare the number of lesions identified using [68Ga]Ga DOTA-5G PET/CT with [18F]-FDG PET/CT.
EXPLORATORY OBJECTIVE:
I. To evaluate the sensitivity of [68Ga]Ga DOTA-5G PET/CT imaging in reference to the tissue staining for αvβ6 integrin by immunohistochemistry (IHC) (positive vs. negative based on SUVmax above background uptake).
OUTLINE:
Patients receive [68Ga]Ga DOTA-5G intravenously (IV) then undergo PET/CT scan 1 and 2 hours later. Patients also undergo blood sample collection throughout the study.
After completion of study intervention, patients are followed up at 1 day and 1 week.
Lead OrganizationUniversity of California Davis Comprehensive Cancer Center
Principal InvestigatorJulie Sutcliffe
