Imaging with 89Zr-DFO-YS5 to detect cancer
Official title: A Pilot PET Imaging Study of [89Zr]DFO-YS5 for Detection of Cancer in Patients With Various Malignancies
Run by University of California, San Francisco · NCT07664397 · Data updated 2026-11-12
This study tests a new PET radiotracer, 89Zr-DFO-YS5, to see if it can show cancer sites in adults with nerve sheath tumors, bladder cancer, or other solid tumors.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Status | Recruiting |
| Started | June 15, 2026 |
| Main results expected | September 30, 2029 |
| Study ends | September 30, 2029 |
| Registry record updated | October 1, 2026 |
| Trial ID | NCT07664397 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with histologically confirmed malignant peripheral nerve sheath tumors, bladder cancer, or other solid tumors, with measurable lesions and adequate organ function.
✕Probably not a fit
Patients whose tumors do not take up the radiotracer or who experience adverse effects may not benefit from this imaging agent.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-center, early-phase PET-imaging study using a novel radiotracer, 89Zr-DFO-YS5, in adults with malignant peripheral nerve sheath tumors, bladder cancer, or advanced solid tumors. Participants receive a one-time dose of the radiotracer and undergo whole-body PET imaging to characterize uptake patterns. Safety is monitored for about one month after administration. The study aims to describe imaging uptake and establish basic safety in this population.
Why it matters
Potential benefit: If successful, the radiotracer could improve visualization of cancer lesions and potentially guide future diagnostics or therapies.
How similar studies have gone: Previous PET-imaging studies with novel radiotracers have shown feasibility, but this exact tracer is investigational and its performance is not yet established.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Histological or cytological confirmation of malignant peripheral nerve sheath tumor, bladder cancer, or solid tumor neoplasm. 2. At least one soft tissue lesion measurable at 1 cm or greater in short axis measurement on cross sectional imaging such as Computerized tomography (CT), magnetic resonance imaging (MRI), or Positron Emission Tomography (PET)/CT (scan imaging as documented in the medical record). Exception: For participants with localized bladder cancer (pre-cystectomy), lesions smaller than 1 centimeter (cm) are permitted, provided there is cystoscopic confirmation of a bladder mass. 3. Clinically able to undergo PET-CT imaging. 4. Age ≥ 18 years. 5. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 or Karnofsky ≥ 50% (see Appendix 1). 6. Adequate organ function as defined below: * Total bilirubin: ≤ 1.5 x institutional upper limit of normal (ULN) (unless elevated due to Gilbert's syndrome and direct bilirubin is within normal limits). * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase (SGOT)): ≤ 3 x ULN. * Alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase (SGPT)): ≤ 3 x ULN. * Estimated creatinine clearance: ≥ 30 mL/min, calculated using the Cockcroft-Gault equation. 7. Females of reproductive potential (defined below) must be willing to undergo a urine or serum pregnancy test (i.e., human chorionic gonadotropin test) within 72 hours before administration of \[89Zr\]DFO-YS5. A female is considered to NOT be of reproductive potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice), if they meet 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). The result of the urine or serum pregnancy test must be negative in order to initiate the \[89Zr\]DFO-YS5 administration. If a urine pregnancy test is positive or equivocal, a confirmatory a serum pregnancy test is required. The individual must be excluded from participation if the serum pregnancy result is positive. Pregnant individuals are excluded from this study because there is an unknown but potential risk for adverse effects in the unborn child secondary to treatment of the study participant with \[89Zr\]DFO-YS5. 8. Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or endpoints of this study are eligible. 9. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: 1. Individuals with a contraindication to PET-CT imaging (e.g., severe claustrophobia) (e.g., implanted devices, metallic objects, or other implants). Participants must be able to undergo either PET-CT. 2. Individuals who are pregnant or breastfeeding/chest-feeding. * Breastfeeding/chestfeeding should be discontinued before administration of \[89Zr\]DFO-YS5. * Females of childbearing potential (defined below) 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. 3. Hypersensitivity to \[89Zr\]DFO-YS5 or any of its excipients. 4. Individuals with any condition or social circumstance that, in the opinion of the investigator, would impair the participant's ability to comply with study procedures.
Where it's running
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University of California, San Francisco
San Francisco, California, United States Recruiting
Study contacts
- Principal investigator: Robert Flavell, MD — University of California, San Francisco
- Study coordinator: Maya Aslam
- Email: Maya.Aslam@ucsf.edu
- Phone: 877-827-3222
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.