Imaging Study of [89Zr]DFO-YS5 for Detecting CD46 Positive Malignancy in Multiple Myeloma
NCT ID: NCT05892393
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
20 participants
INTERVENTIONAL
2023-06-16
2026-09-01
Brief Summary
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Detailed Description
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I. To determine the sensitivity of metastatic lesion detection in multiple myeloma using zirconium Zr 89-DFO-YS5 (\[89Zr\]DFO-YS5 PET, as compared with fludeoxyglucose F-18 (18F-FDG) PET imaging.
SECONDARY OBJECTIVES:
I. To determine the safety of \[89Zr\]DFO-YS5. II. To determine the average organ uptake of \[89Zr\]DFO-YS5. III. To descriptively report the patterns of intra-tumoral uptake of \[89Zr\]DFO-YS5 on whole body PET, including by site of disease, uptake by tumor type, inter-tumoral and inter-patient heterogeneity, and tumor-to-background signal.
IV. To calculate the dosimetry of \[89Zr\]DFO-YS5 in patients with multiple myeloma.
EXPLORATORY OBJECTIVE:
I. To determine the association between uptake (standardized uptake value maximum \[SUVmax\]) of \[89Zr\]DFO-YS5 with 1q amplification by fluorescence in situ hybridization (FISH) on tumor biopsies (when available; FISH may be conducted as part of routine, standard-of-care).
OUTLINE: Participants are assigned to 1 of 2 cohorts based on participant preference.
COHORT A: Participants receive \[89Zr\]DFO-YS5 intravenously (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: 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.
Patients are followed up at 30 days after final scan.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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
Zirconium Zr 89-DFO-YS5
Given IV
Positron Emission Tomography / Computed Tomography (PET/CT)
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 (PET/MRI)
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.
Fludeoxyglucose F-18
Given IV
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
Zirconium Zr 89-DFO-YS5
Given IV
Positron Emission Tomography / Computed Tomography (PET/CT)
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 (PET/MRI)
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.
Fludeoxyglucose F-18
Given IV
Interventions
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Zirconium Zr 89-DFO-YS5
Given IV
Positron Emission Tomography / Computed Tomography (PET/CT)
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 (PET/MRI)
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.
Fludeoxyglucose F-18
Given IV
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Robert Flavell, MD, PhD
OTHER
Responsible Party
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Robert Flavell, MD, PhD
Principal Investigator
Principal Investigators
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Robert Flavell, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California, San Francisco
San Francisco, California, United States
Countries
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Central Contacts
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Facility Contacts
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Role: backup
Other Identifiers
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NCI-2023-04068
Identifier Type: REGISTRY
Identifier Source: secondary_id
23925
Identifier Type: -
Identifier Source: org_study_id
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