RECRUITING

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

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Conditions

Multiple MyelomaPlasma Cell Myeloma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2023-06-16
Study Completion:2026-09-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05892393

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants must have histologically or cytologically confirmed multiple myeloma by International Myeloma Working Group (IMWG) diagnostic criteria
  2. * 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
  3. * Age \>= 18 years
  4. * Total bilirubin =\< 1.5 X institutional upper limit of normal (ULN)
  5. * Aspartate aminotransferase (AST) =\< 3 X ULN
  6. * Alanine aminotransferase (ALT) =\< 3 X ULN
  7. * Creatinine clearance \>= 60 mL/min, calculated using the Cockcroft-Gault equation
  8. * Ability to understand a written informed consent document, and the willingness to sign it
  1. * 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
  2. * Individuals who are pregnant or breastfeeding/chestfeeding.
  3. * - Breast-feeding/chest-feeding should be discontinued before administration of \[89ZR\]DFO-YS5.
  4. * 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.
  5. * - 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.
  6. * - 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).
  7. * 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

Contacts and Locations

Study Contact

Maya Aslam
CONTACT
(415) 514-8987
Maya.Aslam@ucsf.edu

Principal Investigator

Robert Flavell, MD, PhD
PRINCIPAL_INVESTIGATOR
University of California, San Francisco

Study Locations (Sites)

University of California, San Francisco
San Francisco, California, 94143
United States

Collaborators and Investigators

Sponsor: Robert Flavell, MD, PhD

  • Robert Flavell, MD, PhD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-16
Study Completion Date2026-09-01

Study Record Updates

Study Start Date2023-06-16
Study Completion Date2026-09-01

Terms related to this study

Additional Relevant MeSH Terms

  • Multiple Myeloma
  • Plasma Cell Myeloma