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.
Histological or cytological confirmation of malignant peripheral nerve sheath tumor, bladder cancer, or solid tumor neoplasm.
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.
Clinically able to undergo PET-CT imaging or PET-MRI.
Age ≥ 18 years.
Individuals with a contraindication to PET-CT imaging (e.g., severe claustrophobia) or PET-MRI (e.g., implanted devices, metallic objects, or other implants). Participants must be able to undergo either PET-CT or PET-MRI.
Individuals who are pregnant or breastfeeding/chest-feeding. Pregnant and breastfeeding/chest-feeding individuals 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. Females of childbearing potential must have a negative pregnancy test before administration of [89Zr]DFO-YS5, as outlined in inclusion criterion #7. Breastfeeding/chest-feeding should be discontinued before administration of [89Zr]DFO-YS5.
Hypersensitivity to [89Zr]DFO-YS5 or any of its excipients.
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.
Robert Flavell, MD, PhD
Lead sponsor
University of California, San Francisco
Sponsor institution
Kyntra Bio
Collaborator
Fortis Therapeutics, Inc.
Collaborator