Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT05892393

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

Led by Robert Flavell, MD, PhD · Updated on 2025-11-12

20

Participants Needed

1

Research Sites

167 weeks

Total Duration

On this page

Sponsors

R

Robert Flavell, MD, PhD

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must have confirmed multiple myeloma by tissue or cell testing according to IMWG criteria
  • At least one myeloma lesion positive on 18F-FDG PET/CT or PET/MRI, defined by uptake greater than liver
  • Age 18 years or older
  • Total bilirubin less than or equal to 1.5 times the institutional upper limit of normal
  • Aspartate aminotransferase (AST) less than or equal to 3 times the institutional upper limit of normal
  • Alanine aminotransferase (ALT) less than or equal to 3 times the institutional upper limit of normal
  • Creatinine clearance of 60 mL/min or higher or serum creatinine less than or equal to 1.5 times the institutional upper limit of normal
  • Ability to understand and sign informed consent
Not Eligible

You will not qualify if you...

  • Any condition that may prevent compliance with study procedures or affect safety, as judged by the principal investigator
  • Pregnant or breastfeeding individuals
  • Breastfeeding must be stopped before receiving [89Zr]DFO-YS5
  • Females of childbearing potential must have a negative pregnancy test within 72 hours before receiving [89Zr]DFO-YS5
  • Females are considered of childbearing potential unless postmenopausal for 12 months or surgically sterilized
  • Positive or equivocal pregnancy tests exclude participation
  • Unknown or potential risks to unborn or nursing child from [89Zr]DFO-YS5 treatment

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of California, San Francisco

San Francisco, California, United States, 94143

Actively Recruiting

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Research Team

M

Maya Aslam

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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