Imaging Study of [89Zr]DFO-YS5 for Detecting CD46 Positive Malignancy in Multiple Myeloma
Pilot PET Imaging Study of [89Zr]DFO-YS5 for Detecting CD46 Positive Malignancy in Multiple Myeloma
3 other identifiers
interventional
20
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 multiple-myeloma
Started Jun 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 26, 2023
CompletedFirst Posted
Study publicly available on registry
June 7, 2023
CompletedStudy Start
First participant enrolled
June 16, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
November 12, 2025
August 1, 2025
3.1 years
May 26, 2023
November 7, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
Sensitivity of metastatic lesion
Defined as the rate of lesions with positive uptake when compared against 18F-fluorodeoxyglucose (FDG) PET/computed tomography (CT) positivity. Sensitivity estimated based on lesion level without considering the location of the lesions or the possible intracorrelation of the lesions from the same patient by point estimate with its 95% confidence interval.
Up to 1 week
Median maximum standardized uptake value (SUVmax)
The median and range of standardized uptake value maximum (SUVmax) (across all metastatic lesions per participant) in each study cohort will be descriptively reported using mediastinal blood pool and normal organ background uptake values.
Up to 1 week
Median Standardized Uptake Value averaged across lesions (SUVmax-avg)
The median and range of SUVmax-average across all lesions in each study cohort will be descriptively reported using mediastinal blood pool and normal organ background uptake values.
Up to 1 week
Secondary Outcomes (4)
Proportion of participants reporting treatment-related Adverse Events
Up to 35 days
Average organ uptake of [89Zr]DFO-YS5
Up to 1 week
Descriptive patterns of intra-tumoral uptake of [89Zr]DFO-YS5
Up to 1 week
Dosimetry measurements (Cohort B only)
Up to 1 week
Study Arms (2)
Cohort A ([89Zr]DFO-YS5, single scan
EXPERIMENTALParticipants 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
Cohort B ([89Zr]DFO-YS5, multiple scans
EXPERIMENTALParticipants 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
Interventions
Given IV
Positron emission tomography-computed tomography is a nuclear medicine technique which combines, in a single gantry, a positron emission tomography scanner and an x-ray computed tomography scanner, to acquire sequential images from both devices in the same session, which are combined into a single superposed image
Positron emission tomography-magnetic resonance imaging is a hybrid imaging technology that incorporates magnetic resonance imaging soft tissue morphological imaging and positron emission tomography functional imaging.
Given IV
Eligibility Criteria
You may qualify if:
- 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 or serum creatinine \<= 1.5x the institutional upper limit of normal.
- Ability to understand a written informed consent document, and the willingness to sign it
You may not qualify if:
- 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.
- \- If the urine pregnancy test is positive or equivocal, a confirmatory serum pregnancy test is required. In such cases, the individual must be excluded from participation if the serum pregnancy result is positive.
- \- A female is considered to be of childbearing potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice), unless it is documented that the individual meets either of the following two criteria: (1) has reached a postmenopausal state ( \>= 12 continuous months of amenorrhea with no identified cause other than menopause); or (2) has undergone surgical sterilization (i.e., hysterectomy and/or bilateral oophorectomy for removal of uterus and/or ovaries).
- Individuals who are pregnant or breastfeeding/chestfeeding are excluded because there is an unknown but potential risk for adverse effects in the unborn/nursing child secondary to treatment of the study participant with \[89ZR\]-DFO-YS5
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Robert Flavell, MD, PhDlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
University of California, San Francisco
San Francisco, California, 94143, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Flavell, MD, PhD
University of California, San Francisco
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 26, 2023
First Posted
June 7, 2023
Study Start
June 16, 2023
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
November 12, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share