Imaging for detecting cancer cells in multiple myeloma
Pilot PET Imaging Study of [89Zr]DFO-YS5 for Detecting CD46 Positive Malignancy in Multiple Myeloma
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
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT05892393 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have shown promise in using novel imaging agents for cancer detection, but this specific approach is relatively novel.
Eligibility criteria
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 \>= 60 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 this trial is running
San Francisco, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.