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 — DRUG
    Given intravenously (IV)
  • Positron Emission Tomography (PET)-Magnetic resonance imaging (MRI) — PROCEDURE
    Participants may receive a whole-body PET-MRI or a whole body PET-CT
  • Positron Emission Tomography (PET)-Computerized tomography (CT) — PROCEDURE
    Participants 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

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143
Maya Aslam
877-827-3222
Robert Flavell, MD (PRINCIPAL_INVESTIGATOR)

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