This phase I trial tests the safety of [89Zr]DFO-YS5 positron emission tomography (PET) imaging and how well it works to detect CD46 positive cancer cells in patients with multiple myeloma. [89Zr]DFO-YS5 is an imaging agent called a radiopharmaceutical tracer. A radiopharmaceutical tracer uses a small amount of radioactive material that is injected into a vein to help image different areas of the body. [89Zr]DFO-YS5 targets a specialized protein called CD46, which is in certain multiple myeloma cancer cells. A PET/computed tomography (CT) scan or PET/magnetic resonance imaging (MRI) scan is performed after administration of [89Zr]DFO-YS5. A PET scan uses a special camera to detect energy given off from radioactive material to make detailed pictures of areas where [89Zr]DFO-YS5 accumulates in the body. The PET scan is often combined with an MRI or CT scan, which helps to more accurately map the location of where in the body the radioactive material has collected. A CT scan 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. An MRI scan uses radiofrequency waves and a strong magnetic field rather than x-rays to provide detailed pictures of areas inside the body. [89Zr]DFO-YS5 PET scans may improve detection of multiple myeloma.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05892393.
Locations matching your search criteria
United States
California
San Francisco
University of California San FranciscoStatus: Active
Contact: Robert Flavell
Phone: 415-353-3638
PRIMARY OBJECTIVE:
I. To determine the sensitivity of metastatic lesion detection in multiple myeloma using zirconium Zr 89-DFO-YS5 ([89Zr]DFO-YS5 PET, as compared with fludeoxyglucose F-18 (18F-FDG) PET imaging.
SECONDARY OBJECTIVES:
I. To determine the safety of [89Zr]DFO-YS5.
II. To determine the average organ uptake of [89Zr]DFO-YS5.
III. To descriptively report the patterns of intra-tumoral uptake of [89Zr]DFO-YS5 on whole body PET, including by site of disease, uptake by tumor type, inter-tumoral and inter-patient heterogeneity, and tumor-to-background signal.
IV. To calculate the dosimetry of [89Zr]DFO-YS5 in patients with multiple myeloma.
EXPLORATORY OBJECTIVE:
I. To determine the association between uptake (standardized uptake value maximum [SUVmax]) of [89Zr]DFO-YS5 with 1q amplification by fluorescence in situ hybridization (FISH) on tumor biopsies (when available; FISH may be conducted as part of routine, standard-of-care).
OUTLINE: Patients are assigned to 1 of 2 cohorts based on patient preference.
COHORT A: Patients receive [89Zr]DFO-YS5 intravenously (IV) and undergo a single PET/CT or PET/MRI scan 5-7 days post-injection. Patients also receive fludeoxyglucose F-18 IV and undergo PET/CT or PET/MRI scan within 12 weeks prior to day 1.
COHORT B: Patients receive [89Zr]DFO-YS5 IV and undergo four PET/CT or PET/MRI scans on days 1, 2, 3-4, and 5-7 post-injection. Patients also receive fludeoxyglucose F-18 IV and undergo PET/CT or PET/MRI scan within 12 weeks prior to day 1.
Patients are followed up at 30 days after final scan.
Lead OrganizationUniversity of California San Francisco
Principal InvestigatorRobert Flavell
