Characterizing the Microvascular Environment of Bladder Cancer With Super-Resolution Ultrasound Localization Microscopy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Bladder Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The project will include 30 patients with bladder cancer who are candidates for bladder removal. After signing the consent form, the study team will collect some clinical data, such as age, past medical history, past surgical history, and information about your current disease. At the day of surgery, after putting participants into sleep and before surgery begins, the study team will do a novel ultrasound called "Super-Resolution Ultrasound Localization Microscopy" to check if there is still disease in the bladder. The team will then compare the results of this investigational ultrasound with the final pathology and other imaging studies.
Primary outcome measures
- Presence and stage of residual bladder cancer at the time of RC. [Time frame: From enrollment to first post-cystectomy follow-up visit (1 month)]
Eligibility criteria
Inclusion criteria
- Adults > 18 years
- Histological evidence of urothelial cancer of the bladder for which radical cystectomy is recommended as per the treating physician (e.g., MIBC or high-risk NMIBC, such as high-grade T1 BCG refractory and worrisome histological variants)
Exclusion criteria
- Known or suspected hypersensitivity to sulfur hexafluoride lipid microsphere or its components, such as polyethylene glycol (PEG).
- Pregnancy or breastfeeding
- Decline to participate in the study
- Participants who had serious allergic reactions to COVID-19 vaccination.
- Participants with unstable conditions such as hospital in-patients, ICU patients, or high-risk cardiac diseases.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Duke University — Durham
Identifiers
NCT: NCT06986304 · Pro00117744