Safety and Effectiveness of 89ZrDFO-YS5 PET Imaging to Detect CD46 Positive Multiple Myeloma Lesions

What this Trial Is About

Researchers are evaluating the use of a new imaging agent called 89ZrDFO-YS5 to detect CD46 positive cancer cells in patients with multiple myeloma. This phase I trial aims to test the safety of this agent and compare its effectiveness in detecting metastatic lesions with a standard PET scan using fludeoxyglucose F-18. The study also explores detailed patterns of tumor uptake and radiation dose measurements. Participants receive the 89ZrDFO-YS5 agent intravenously and undergo either a single PETCT or PETMRI scan 5 to 7 days after injection Cohort A, or four scans on days 1, 2, 3-4, and 5-7 post-injection Cohort B. All participants also receive a fludeoxyglucose F-18 injection and a PET scan within 28 days before the first day of the study imaging. The study includes a follow-up visit 30 days after the final scan to assess safety. During the study, participants undergo multiple imaging scans to monitor how well the new agent detects cancer lesions and measure its uptake in organs and tumors. Safety is tracked by recording any treatment-related side effects. Key outcomes include the sensitivity of lesion detection, standardized uptake values, organ uptake, and radiation dosimetry. The total participation duration covers the imaging period plus the 30-day follow-up after the last scan.

Imaging Study of [89Zr]DFO-YS5 for Detecting CD46 Positive Malignancy in Multiple Myeloma