Bladder Cancer study: [89Zr]DFO-YS5
Official title Imaging Study of [89Zr]DFO-YS5 for Cancer Detection
ClinicalTrials.gov ID: NCT07664397
What this study is testing
What is [89Zr]DFO-YS5?
This is an investigational imaging agent being studied to help doctors see where certain cancers, like bladder cancer, are located in the body. is designed to attach to specific cells in the body so that a special camera can take pictures of them.
Also referred to as 89Zirconium-89 DFO conjugated to the YS5 monoclonal antibody.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is looking at how well a new scan shows cancer. It checks if the scan can spot nerve sheath tumors, bladder cancer, or other solid tumors.
- Who it's for
- You may be able to join if you have a solid tumor like bladder cancer or a nerve sheath tumor.
- What's involved
- You would get a special scan called PET. This uses a new tracer to help doctors see your cancer.
- Time commitment
- The study involves one visit for the scan at a single center.
- Phase 1: an early, usually small safety study
- Time commitment: about 1 month
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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).
You likely can't join if
- Individuals with a contraindication to PET-CT imaging (e.g., severe claustrophobia) (e.g., implanted devices, metallic objects, or other implants).
- 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...
- 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...
See the full eligibility criteria
- 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...
- 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).
- 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.
- 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.
- 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.
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 1 month per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at San Francisco, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.