Brief Title: Imaging Study of [89Zr]DFO-YS5 for Cancer Detection

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Mean maximum standard uptake value (SUVmax-avg) on Positron Emission Tomography (PET) scan

Primary Outcome 1 - Timeframe: Up to 8 days

Primary Outcome 2 - Measure: Median intra-tumoral SUVmax

Primary Outcome 2 - Timeframe: Up to 8 days

Primary Outcome 3 - Measure: Tumor-to-background signal (Ratio)

Primary Outcome 3 - Timeframe: Up to 8 days

CONDITION

• Bladder Cancer
• Nerve Sheath Tumor
• Nerve Sheath Tumors
• Solid Tumor Malignancies
• Solid Tumor Cancer
• Solid Tumor Neoplasms
• Advanced Solid Tumor
• Bladder Neoplasm
• Nerve Sheath Neoplasms
• Nerve Sheath Tumor
• Nos
• Solid Tumor
• Adult
• Solid Carcinoma

ELIGIBILITY

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Robert Flavell, MD

Role: Principal Investigator

Affiliation: University of California, San Francisco

Overall Contact

Name: Maya Aslam

Phone: 877-827-3222

Email: [email protected]

LOCATION