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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06986304

Acronym

SR-ULM BC

Enrollment

Registered

2025-05-23

Start date

2025-10-28

Completion date

2027-04-01

Last updated

2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Contacts

CONTACTMichael Abern, M.D.

michael.abern@duke.edu919-684-5057

PRINCIPAL_INVESTIGATORMichael Abern, M.D.

Duke University

Outcome results