This early phase I trial studies how well 64Cu-LLP2A works in diagnosing patients with multiple myeloma. Positron emission tomography (PET) imaging with an imaging medication called fludeoxyglucose F-18 (FDG) (a radioactive form of sugar) is often used in combination with a PET/computed tomography (CT) scanner to get a better picture of the metabolism or how active the multiple myeloma is in the body. Giving 64Cu-LLP2A before a PET/magnetic resonance imaging (MRI) or PET/CT scan may work better in helping researchers understand the status of the disease.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03804424.
PRIMARY OBJECTIVES:
I. Evaluate the feasibility of imaging patients with multiple myeloma (MM) with Copper Cu 64-CB-TE1A1P-PEG4-LLP2A (64Cu-LLP2A)-PET/magnetic resonance (MR).
II. To calculate human dosimetry of 64Cu-LLP2A and assess the safety 64Cu-LLP2A administration.
III. To determine the optimal imaging time after injection of 64Cu-LLP2A that yields best image quality and tumor-to-non-tumor ratio for visual and quantitative analysis of the images.
IV. To assess the image quality and lesion detection of 64Cu-LLP2A-PET/MR images.
SECONDARY OBJECTIVE:
I. To evaluate the relationship between uptake of 64Cu-LLP2A and overall tumor burden assessed on 64Cu-LLP2A-PET images and serum protein markers of myeloma (such as M-protein) and the plasma cell fraction within the bone marrow.
OUTLINE: Patients are assigned to 1 of 2 cohorts.
COHORT I: Patients receive 64Cu-LLP2A intravenously (IV). Six patients immediately undergo a dynamic scan over 60 minutes. Patients also undergo 2-3 PET/MRI or PET/CT scans immediately after, 1-3 hours after, 3-8 hours after, or 18-30 hours after receiving 64Cu-LLP2A. Six patients undergo body imaging at 3 time points and do not undergo dynamic imaging.
COHORT II: Twenty patients receive 64Cu-LLP2A IV and then undergo a dynamic scan over 60 minutes. Patients then undergo PET/MRI or PET/CT after completion of the dynamic scan or the best time point determined from Cohort I (between 1-30 hours later).
After completion of study, patients are followed up at 24 hours to 14 days.
Lead OrganizationSiteman Cancer Center at Washington University
Principal InvestigatorFarrokh Dehdashti