Bladder CancerPhase 1NCT07664397
Imaging Study of [89Zr]DFO-YS5 for Cancer Detection
A Phase 1 study testing [89Zr]DFO-YS5 and Positron Emission Tomography (PET)-Computerized tomography (CT) in people with Bladder Cancer and Nerve Sheath Tumor, run by Robert Flavell, MD, PhD at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, Nerve Sheath Tumor, Nerve Sheath Tumors
- What is being tested?
- [89Zr]DFO-YS5 and Positron Emission Tomography (PET)-Computerized tomography (CT)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2026to 30 Sep 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 or Karnofsky ≥ 50% (see Appendix 1).
- Adequate organ function as defined below:
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- 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.
- 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.
- 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.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- 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.
- 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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
Maya Aslam, 877-827-3222, Maya.Aslam@ucsf.edu
cancertrials@ucsf.edu
About this study
Official title: A Pilot PET Imaging Study of [89Zr]DFO-YS5 for Detection of Cancer in Patients With Various Malignancies
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To descriptively report patterns of [89Zr]DFO-YS5 uptake on whole-body PET.
SECONDARY OBJECTIVE:
II. To determine the safety of [89Zr]DFO-YS5.
OUTLINE:
Participants will be administered a single dose of [89Zr]DFO-YS5 followed by whole-body positron emission tomography (PET) imaging at a single time point. All participants will be followed for adverse events for approximately Participants in the main study will be followed for adverse events for approximately 1 month after [89Zr]DFO-YS5 radiotracer administration.
- Conditions
- Bladder Cancer, Nerve Sheath Tumor, Nerve Sheath Tumors, Solid Tumor Malignancies, Solid Tumor Cancer, Solid Tumor Neoplasms
- Being tested
- [89Zr]DFO-YS5, Positron Emission Tomography (PET)-Computerized tomography (CT)
- Keywords
- Imaging Study
- Medical subject headings
- Urinary Bladder Neoplasms, Nerve Sheath Neoplasms, Pyloric Stenosis, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[89Zr]DFO-YS5Drug
Also called 89Zirconium-89 DFO conjugated to the YS5 monoclonal antibody
Given intravenously (IV)
Positron Emission Tomography (PET)-Computerized tomography (CT)Procedure or surgery
Also called PET/CT, PET-CT
Participants may receive a whole-body PET-CT or a whole-body PET-MRI
| Study group | Role | What they receive |
|---|---|---|
| Treatment ([89Zr]DFO-YS5) | Experimental | 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. Receives: Drug: [89Zr]DFO-YS5; Procedure: Positron Emission Tomography (PET)-Computerized tomography (CT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean maximum standard uptake value (SUVmax-avg) on Positron Emission Tomography (PET) scan
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.
Measured: Up to 8 days
Median intra-tumoral SUVmax
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.
Measured: Up to 8 days
Tumor-to-background signal (Ratio)
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
Measured: Up to 8 days
Secondary outcomes (1)
Proportion of participants with reported treatment-emergent adverse events
The proportion of participants with reported treatment-emergent Adverse events (AEs) will be classified and graded according to the NCI CTCAE version. 5.0 by severity and type evaluated from the time of administration through the Day 6-8 Visit (120-168 hours post-dose).
Measured: Up to 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start15 Jun 2026
- Primary completion30 Sep 2029 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Robert Flavell, MD, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Kyntra Bio, Fortis Therapeutics, Inc.
- Responsible party
- Sponsor-investigator, Robert Flavell, MD, PhD, University of California, San Francisco
- Investigators
- Robert Flavell, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07664397
- Sponsor's protocol ID
- 26921
- Other IDs
- NCI-2026-04664
- Status last verified
- Sep 2026
- First submitted
- 17 Jun 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data may be shared with study collaborators during the course of data collection.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot PET Imaging Study of [89Zr]DFO-YS5 for Detection of Cancer in Patients With Various Malignancies
- ClinicalTrials.gov ID
- NCT07664397
- Acronym / sponsor ID
- 26921
- Conditions
- Bladder Cancer, Nerve Sheath Tumor, Nerve Sheath Tumors, Solid Tumor Malignancies, Solid Tumor Cancer, Solid Tumor Neoplasms
- Keywords
- Imaging Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Robert Flavell, MD, PhDUniversity, hospital or other
- Collaborators
- Kyntra Bio, Fortis Therapeutics, Inc.
- Study start
- 15 Jun 2026 (actual)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- To descriptively report patterns of [89Zr]DFO-YS5 uptake on whole-body PET.
SECONDARY OBJECTIVE:
II. To determine the safety of [89Zr]DFO-YS5.
OUTLINE:
Participants will be administered a single dose of [89Zr]DFO-YS5 followed by whole-body positron emission tomography (PET) imaging at a single time point. All participants will be followed for adverse events for approximately Participants in the main study will be followed for adverse events for approximately 1 month after [89Zr]DFO-YS5 radiotracer administration.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment ([89Zr]DFO-YS5) | Experimental | Drug: [89Zr]DFO-YS5, Procedure: Positron Emission Tomography (PET)-Computerized tomography (CT)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 or Karnofsky ≥ 50% (see Appendix 1).
Key exclusion criteria (8 listed)
- 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.
- Individuals who are pregnant or breastfeeding/chest-feeding.
- 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.
- Hypersensitivity to [89Zr]DFO-YS5 or any of its excipients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [89Zr]DFO-YS5Also: 89Zirconium-89 DFO conjugated to the YS5 monoclonal antibodyGiven intravenously (IV) | Drug | Treatment ([89Zr]DFO-YS5) |
| Positron Emission Tomography (PET)-Computerized tomography (CT)Also: PET/CT, PET-CTParticipants may receive a whole-body PET-CT or a whole-body PET-MRI | Procedure or surgery | Treatment ([89Zr]DFO-YS5) |
Primary outcome
Mean maximum standard uptake value (SUVmax-avg) on Positron Emission Tomography (PET) scan
Time frame: Up 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 SUVmax
Time frame: Up 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)
Time frame: 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
1 secondary outcome
Proportion of participants with reported treatment-emergent adverse events
Time frame: Up to 8 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified data may be shared with study collaborators during the course of data collection.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert Flavell, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [89Zr]DFO-YS5 and Positron Emission Tomography (PET)-Computerized tomography (CT) in people with Bladder Cancer and Nerve Sheath Tumor, run by Robert Flavell, MD, PhD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maya Aslam (877-827-3222, Maya.Aslam@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean maximum standard uptake value (SUVmax-avg) on Positron Emission Tomography (PET) scan (time frame: Up to 8 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.