Imaging Study of [89Zr]DFO-YS5 for Detecting CD46 Positive Malignancy in Multiple Myeloma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorRobert Flavell, MD, PhD
About this trial
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 criteria
Qualifiers
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)
Disqualifiers
Any condition that, in the opinion of the principal investigator, would impair the participants' ability to comply with study procedures or interfere with the safety of the investigational regimen
Individuals who are pregnant or breastfeeding/chestfeeding.
- Breast-feeding/chest-feeding should be discontinued before administration of [89ZR]DFO-YS5.
Females of childbearing potential must have a negative urine or serum pregnancy test (i.e., human chorionic gonadotropin test) within 72 hours prior to administration of [89ZR]-DFO-YS5.
Trial design
Treatments tested in this trial
- Zirconium Zr 89-DFO-YS5
- Positron Emission Tomography / Computed Tomography (PET/CT)
- Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI)
- Fludeoxyglucose F-18
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Robert Flavell, MD, PhD
Lead sponsor
University of California, San Francisco
Sponsor institution
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov