Recruiting

Ultrasound Localization

Sponsor:

Duke University

Code:

NCT06986304

Conditions

Bladder Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Bladder Cancer

Study ID

NCT06986304

Start date

Oct 28, 2025

Status verified date

Apr, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • 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) ]

Central Contacts and Locations

Central contacts

Locations

Duke University

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Alireza Ghoreifinejadian, M.D.

919-684-8111

Principal Investigator:

Michael Abern, M.D.

More Information

Sponsor

Duke University

Last update posted

May 4, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-05-04.