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

Trial Title: Imaging Study of [89Zr]DFO-YS5 for Detecting CD46 Positive Malignancy in Multiple Myeloma

NCT ID: NCT05892393

Condition: Multiple Myeloma
Plasma Cell Myeloma

Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Fluorodeoxyglucose F18

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Single Group Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Zirconium Zr 89-DFO-YS5
Description: Given IV
Arm group label: Cohort A ([89Zr]DFO-YS5, single scan
Arm group label: Cohort B ([89Zr]DFO-YS5, multiple scans

Other name: (89)Zr-DFO-YS5

Other name: 89Zr DFO-YS5

Intervention type: Procedure
Intervention name: Positron Emission Tomography / Computed Tomography (PET/CT)
Description: 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
Arm group label: Cohort A ([89Zr]DFO-YS5, single scan
Arm group label: Cohort B ([89Zr]DFO-YS5, multiple scans

Other name: PET/CT

Intervention type: Procedure
Intervention name: Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI)
Description: 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.
Arm group label: Cohort A ([89Zr]DFO-YS5, single scan
Arm group label: Cohort B ([89Zr]DFO-YS5, multiple scans

Other name: PET/MRI

Intervention type: Other
Intervention name: Fludeoxyglucose F-18
Description: Given IV
Arm group label: Cohort A ([89Zr]DFO-YS5, single scan
Arm group label: Cohort B ([89Zr]DFO-YS5, multiple scans

Other name: Fludeoxyglucose (18F)

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.

Detailed description: PRIMARY OBJECTIVE: 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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - 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 Exclusion Criteria: - 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University of California, San Francisco

Address:
City: San Francisco
Zip: 94143
Country: United States

Status: Recruiting

Contact:
Last name: Maya Aslam

Phone: 415-514-8987
Email: Maya.Aslam@ucsf.edu

Contact backup:

Phone: 877-827-3222
Email: cancertrials@ucsf.edu

Investigator:
Last name: Robert Flavell, MD, PhD
Email: Principal Investigator

Start date: June 16, 2023

Completion date: September 1, 2026

Lead sponsor:
Agency: Robert Flavell, MD, PhD
Agency class: Other

Collaborator:
Agency: National Cancer Institute (NCI)
Agency class: NIH

Source: University of California, San Francisco

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05892393