Imaging Study of [89Zr]DFO-YS5 for Cancer Detection
Part of paid clinical trials in San Francisco, California.
- Sponsor
- Robert Flavell, MD, PhD
- Study ID
- NCT07664397
- Phase
- PHASE1
- Status
- Not Yet Recruiting
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Conditions
- Advanced Solid Tumor
- Bladder Cancer
- Bladder Neoplasm
- Nerve Sheath Neoplasms
- Nerve Sheath Tumor
- Nerve Sheath Tumor, Nos
- Nerve Sheath Tumors
- Solid Carcinoma
- Solid Tumor Cancer
- Solid Tumor Malignancies
- Solid Tumor Neoplasms
- Solid Tumor, Adult
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- [89Zr]DFO-YS5 — DRUGGiven intravenously (IV)
- Positron Emission Tomography (PET)-Magnetic resonance imaging (MRI) — PROCEDUREParticipants may receive a whole-body PET-MRI or a whole body PET-CT
- Positron Emission Tomography (PET)-Computerized tomography (CT) — PROCEDUREParticipants may receive a whole-body PET-CT or a whole-body PET-MRI
Study Details
This is a single-center, pilot, PET-imaging study of the novel radiotracer 89Zirconium-89 DFO conjugated to the YS5 monoclonal antibody (\[89Zr\]DFO-YS5) in participants with nerve sheath tumor, bladder cancer, or advanced solid tumor neoplasms.
Key Dates
- Start date
- Aug 1, 2026
- Status verified
- Jun 2026
- Primary completion
- Sep 30, 2029
- Completion
- Sep 30, 2029
Study Design
- Enrollment
- 40 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- DIAGNOSTIC
Arms
- Experimental: Treatment ([89Zr]DFO-YS5)Participants will be administered a single, intravenous microdose (1.0 - 3.0 mCi) of \[89Zr\]DFO-YS5, followed by whole-body positron emission tomography (PET) imaging conducted 120-168 hours after \[89Zr\]DFO-YS5 administration (i.e., on Day 6-8). Participants will be followed for treatment-emergent adverse events for up to 35 days.
Primary Outcome Measure
Mean maximum standard uptake value (SUVmax-avg) on Positron Emission Tomography (PET) scan [ Time Frame: Up to 8 days ]
Central Contacts
- Maya Aslam877-827-3222
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | Robert Flavell, MD (PRINCIPAL_INVESTIGATOR) |
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