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

Not yet recruiting

• Conditions: Bladder Cancer

• Registration Number: NCT06986304
• Lead Sponsor: Duke University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-15
• Study First Submitted QC: 2025-05-15
• Last Update Submitted: 2025-05-15
• Study First Posted: 2025-05-23
• Last Update Posted: 2025-05-23
• Study Start: 2026-01
• Primary Completion: 2027-01
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence and stage of residual bladder cancer at the time of RC.	From enrollment to first post-cystectomy follow-up visit (1 month)	The primary outcome variable is the presence and stage of residual bladder cancer at the time of RC. Statistical tests such as logistic regression will be applied to assess the accuracy of quantitative SR-ULM biomarkers in detecting residual bladder cancer.

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States