NCT05892393RecruitingPhase 1
Imaging Study of [89Zr]DFO-YS5 for Detecting CD46 Positive Malignancy in Multiple Myeloma
Pilot PET Imaging Study of [89Zr]DFO-YS5 for Detecting CD46 Positive Malignancy in Multiple Myeloma
Source: ClinicalTrials.gov · Last updated 16 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 26 May 2023
- Start date
- 16 Jun 2023
- Primary completion date
- 31 Jan 2027
- Lead sponsor
- Robert Flavell, MD, PhD
- Diseases
- Multiple myeloma
- NCT number
- NCT05892393
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 20
- From 16 Jun 2023 to the primary completion date, 31 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- \- 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).
Other illness
- 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
Lab values
- 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.
Other
- Individuals who are pregnant or breastfeeding/chestfeeding.
- \- Breast-feeding/chest-feeding should be discontinued before administration of \[89ZR\]DFO-YS5.
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.