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

a study on Multiple Myeloma

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California
Dates
study started
estimated completion
Principal Investigator
by Robert Flavell, MD, PhD
Headshot of Robert Flavell
Robert Flavell

Description

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.

Official Title

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

Details

PRIMARY OBJECTIVE:

  1. 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:

  1. 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:

  1. 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.

Keywords

Multiple Myeloma, Plasma Cell Myeloma, Plasma Cell Neoplasms, Fluorodeoxyglucose F18, Zirconium Zr 89-DFO-YS5, Positron Emission Tomography / Computed Tomography (PET/CT), Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI), Fludeoxyglucose F-18

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • Any condition that, in the opinion of the principal investigator, would impair the patient's ability to comply with study procedures or interfere with the safety of the investigational regimen
  • Patients who have received the same antibody (YS5) earlier as part of therapy or detection
  • 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

Location

  • UCSF accepting new patients
    San Francisco California 94143 United States

Lead Scientist at UCSF

  • Robert Flavell, MD, PhD
    Robert Flavell, MD, PhD, is the Chief of Molecular Imaging and Therapeutics Clinical Section in the Department of Radiology and Biomedical Imaging at the University of California, San Francisco. He received his medical degree from Weill Cornell Medical College, and his PhD from the Rockefeller University as part of the Tri-Institutional MD PhD program.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Robert Flavell, MD, PhD
ID
NCT05892393
Phase
Phase 1 Multiple Myeloma Research Study
Study Type
Interventional
Participants
Expecting 20 study participants
Last Updated
Contact us about this trial