Characterizing the Microvascular Environment of Bladder Cancer With Super-Resolution Ultrasound Localization Microscopy (SR-ULM BC)

Duke University

Status: Not yet enrolling

Conditions: Bladder Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT06986304

Pro00117744

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.