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

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug, Other
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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, and \[89Zr\]DFO-YS5 PET scans may improve detection of multiple myeloma.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Participants must have histologically or cytologically confirmed multiple myeloma by International Myeloma Working Group (IMWG) diagnostic criteria

• At least one positive myelomatous lesion found on 18F-FDG PET/CT or PET/MRI. A positive lesion is defined as uptake greater than liver on FDG PET, based on the Italian myeloma criteria for PET use (IMPeTUs) criteria

• Age \>= 18 years

• Total bilirubin =\< 1.5 X institutional upper limit of normal (ULN)

• Aspartate aminotransferase (AST) =\< 3 X ULN

• Alanine aminotransferase (ALT) =\< 3 X ULN

• Creatinine clearance \>= 60 mL/min, calculated using the Cockcroft-Gault equation

• Ability to understand a written informed consent document, and the willingness to sign it

Locations
United States
California
University of California, San Francisco
RECRUITING
San Francisco
Contact Information
Primary
Maya Aslam
Maya.Aslam@ucsf.edu
(415) 514-8987
Time Frame
Start Date: 2023-06-16
Estimated Completion Date: 2026-09-01
Participants
Target number of participants: 20
Treatments
Experimental: Cohort A ([89Zr]DFO-YS5, single scan
Participants receive \[89Zr\]DFO-YS5 IV and undergo a single PET/CT or PET/MRI scan 5-7 days post-injection. Participants also receive fludeoxyglucose F-18 IV and undergo PET/CT or PET/MRI scan within 28 days prior to day 1
Experimental: Cohort B ([89Zr]DFO-YS5, multiple scans
Participants 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. Participants also receive fludeoxyglucose F-18 IV and undergo PET/CT or PET/MRI scan within 28 days prior to day 1
Related Therapeutic Areas
Sponsors
Leads: Robert Flavell, MD, PhD
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov