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

This study is looking at a new imaging agent called [89Zr]DFO-YS5 to help detect certain cancers. Researchers want to see how this agent, which is a type of monoclonal antibody, shows up on special scans. You might be able to join if you have bladder cancer, a nerve sheath tumor, or another solid tumor cancer that has been confirmed by a biopsy. You also need to have at least one tumor that is 1 cm or larger. The main goal is to see how well [89Zr]DFO-YS5 is absorbed by tumors using PET scans. They will also be checking for any side effects. The study plans to enroll 40 participants.

Study design: This is a single-center pilot study. It aims to enroll 40 participants.
What's involved: You will receive a single dose of [89Zr]DFO-YS5 intravenously (IV), followed by a whole-body PET-MRI or PET-CT scan.
Compensation: Not stated in the trial record.
Follow-up: You will be followed for adverse events for approximately 1 month after receiving the [89Zr]DFO-YS5.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Not Yet Recruiting

PHASE1Ages 18+InterventionalDiagnostic

Robert Flavell, MD, PhD

~40 participants

Updated 2026-06-24 on ClinicalTrials.gov

What's tested:[89Zr]DFO-YS5Positron Emission Tomography (PET)-Magnetic resonance imaging (MRI)Positron Emission Tomography (PET)-Computerized tomography (CT)

At a glance

Recruiting sites

0 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Mean maximum standard uptake value (SUVmax-avg) on Positron Emission Tomography (PET) scan

Measured over Up to 8 days

+2 more outcomes measured

Conditions

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

NCT07664397

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

University of California, San Francisco
San Francisco, Californiastudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

Robert Flavell, MD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco

Who to contact

Maya Aslam

[email protected]

877-827-3222

Email the study team

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Eligibility criteria

Inclusion

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: ≥ 60 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.

What this trial measures

Mean maximum standard uptake value (SUVmax-avg) on Positron Emission Tomography (PET) scanUp to 8 days
A volume of interest (VOI) will be placed around each lesion, and the calculated maximum standard uptake value (SUVmax) will be recorded for each lesion. Adjusted SUVmax data will then be averaged across up to 15 lesions within a given patient (SUVmax-avg) at each time point. In order to avoid clustering effects, analyses will be limited to the five largest osseous metastases, five largest lymph node metastases, and five largest visceral/soft tissue metastases. Metastatic lesion location, size (bidimensional axial measurement), and SUVmax will be tabulated. This will be conducted for all lesions.
Median intra-tumoral SUVmaxUp to 8 days
The median and range for intra-tumoral SUVmax within metastatic lesions will be descriptively reported, to assess for intra-tumoral heterogeneity and differences in uptake by site of disease.
Tumor-to-background signal (Ratio)Up to 8 days
The tumor-to-background signal refers to comparing the standardized uptake value (SUV) of a lesion (tumor) to the SUV of a nearby normal organ or tissue that serves as a "background" reference. The ratio of the tumor-to-background signal on PET scan (normal organ as background uptake values) will be calculated as the SUVmax of tumor divided by the SUV of background organ

Trialytics