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Clinical trial Recruiting at 1 site Phase 1 Interventional Ages 18 and up

Imaging for detecting cancer cells in multiple myeloma

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

Run by University of California, San Francisco · NCT05892393 · Data updated 2026-11-12

This study is testing a new imaging agent to see if it can better detect cancer cells in people with multiple myeloma compared to standard imaging methods.

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment20 (estimated)
SponsorUniversity of California, San Francisco
Academic / other
Locations1 site (San Francisco, California)
StatusRecruiting
StartedJune 16, 2023
Main results expectedJanuary 31, 2027
Study endsMarch 1, 2027
Registry record updatedSeptember 16, 2026
Trial IDNCT05892393 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 and older with confirmed multiple myeloma and at least one positive lesion detected by standard PET imaging.

Probably not a fit

Patients who are pregnant or have conditions that impair their ability to comply with study procedures may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase I trial evaluates the safety and effectiveness of the radiopharmaceutical tracer [89Zr]DFO-YS5 in detecting CD46 positive cancer cells in patients with multiple myeloma. Participants will receive [89Zr]DFO-YS5 intravenously and undergo PET/CT or PET/MRI scans to assess the sensitivity of this imaging agent compared to traditional fludeoxyglucose F-18 PET imaging. The study aims to gather data on organ uptake, intra-tumoral patterns, and dosimetry of [89Zr]DFO-YS5, while also exploring its association with genetic markers in tumor biopsies. Participants will be assigned to different cohorts based on their preferences for the imaging schedule.

Why it matters

Potential benefit: If successful, this study could lead to improved detection of multiple myeloma, allowing for better treatment planning and outcomes.

How similar studies have gone: Other studies have shown promise in using novel imaging agents for cancer detection, but this specific approach is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion 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 \>= 30 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:

* 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

Where it's running

  • University of California, San Francisco
    San Francisco, California, United States     Recruiting

Study contacts

  • Principal investigator: Robert Flavell, MD, PhD — University of California, San Francisco
  • Study coordinator: Maya Aslam
  • Email: Maya.Aslam@ucsf.edu
  • Phone: (415) 514-8987

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.