Actively Recruiting
Pilot PET Imaging Study of [89Zr]DFO-YS5 for Detecting CD46 Positive Malignancy in Multiple Myeloma
Led by Robert Flavell, MD, PhD · Updated on 2025-11-12
20
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
R
Robert Flavell, MD, PhD
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a new imaging agent called [89Zr]DFO-YS5 in detecting CD46 positive cancer cells in patients with multiple myeloma. This phase I trial compares [89Zr]DFO-YS5 PET scans to standard fludeoxyglucose F-18 PET imaging to assess how well it identifies cancerous lesions. The study also examines how much of the tracer accumulates in organs and tumors, and explores its relationship with specific tumor genetic features. Participants are assigned to one of two groups based on their preference. In Cohort A, participants receive [89Zr]DFO-YS5 intravenously and have a single PET/CT or PET/MRI scan 5 to 7 days later, along with a prior fludeoxyglucose F-18 scan within 28 days before treatment. In Cohort B, participants receive [89Zr]DFO-YS5 and undergo four PET/CT or PET/MRI scans over several days after injection, plus a prior fludeoxyglucose F-18 scan. After the final scan, participants are followed up for 30 days. During the study, participants undergo various imaging scans to track the tracer's uptake and distribution. Researchers measure the sensitivity of lesion detection, standardized uptake values, organ uptake, patterns of tumor uptake, and radiation dosimetry. Safety is monitored by recording any treatment-related side effects up to 35 days after injection. The total participation includes scan visits and a safety follow-up period to ensure thorough evaluation of the imaging agent.
CONDITIONS
Brief Title
Imaging Study of [89Zr]DFO-YS5 for Detecting CD46 Positive Malignancy in Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have histologically or cytologically confirmed multiple myeloma by International Myeloma Working Group diagnostic criteria
- At least one positive myelomatous lesion found on 18F-FDG PET/CT or PET/MRI, defined as uptake greater than liver
- Age 18 years or older
- Total bilirubin less than or equal to 1.5 times institutional upper limit of normal
- Aspartate aminotransferase (AST) less than or equal to 3 times upper limit of normal
- Alanine aminotransferase (ALT) less than or equal to 3 times upper limit of normal
- Creatinine clearance of at least 60 mL/min or serum creatinine less than or equal to 1.5 times institutional upper limit of normal
- Ability to understand and sign informed consent
You will not qualify if you...
- Any condition that would impair the ability to comply with study procedures or affect safety of the investigational regimen
- Pregnant or breastfeeding/chestfeeding individuals
- Females of childbearing potential without a negative pregnancy test within 72 hours prior to study drug administration
- Breastfeeding must be discontinued before administration of [89Zr]DFO-YS5
- Individuals with positive or equivocal pregnancy tests confirmed positive by serum test
- Females not meeting criteria for postmenopausal state or surgical sterilization are excluded if pregnancy tests are positive or not done
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 days before [89Zr]DFO-YS5 injection
Participants receive fludeoxyglucose F-18 intravenously and undergo a PET/CT or PET/MRI scan within 28 days prior to the first administration of [89Zr]DFO-YS5.
1 visit (in-person)
Duration - 5 to 7 days post-injection
Participants receive [89Zr]DFO-YS5 intravenously and undergo PET/CT or PET/MRI scans to detect CD46 positive malignancy. Cohort A has one scan 5 to 7 days after injection. Cohort B has four scans on days 1, 2, 3-4, and 5-7 post-injection.
1 to 4 visits depending on cohort assignment (in-person)
Duration - Approximately 30 days after the last scan
Participants are followed up to assess safety and any treatment-related adverse events after the final imaging scan.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
Research Team
M
Maya Aslam
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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