Characterizing the Microvascular Environment of Bladder Cancer With Super-Resolution Ultrasound Localization Microscopy

Recruiting now

Conditions studied: Bladder Cancer

In brief

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.

Key facts

Study ID: NCT06986304
Run by: Duke University
People needed: 30
Starts: 2025-10-28
Expected to finish: 2027-04-01
Last updated by the study team: 2026-05-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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)

You may not qualify if…

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.

Where it is running

Duke University — Durham, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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