Observational Study of Super-Resolution Ultrasound for Bladder Cancer

This study is looking at a new type of ultrasound called "Super-Resolution Ultrasound Localization Microscopy" to see how well it can find bladder cancer. It includes 30 patients who have bladder cancer and are planning to have their bladder removed. Before your surgery, while you are asleep, the study team will use this special ultrasound to check for cancer in your bladder. The results from this ultrasound will then be compared with the findings from your surgery and other imaging tests. This helps researchers understand if this new ultrasound can accurately detect cancer that is still present.

Study design
This is an observational study involving 30 participants. It is not testing a new treatment, but rather a new way to image bladder cancer.
What's involved
If you join, the study team will collect your medical history. On the day of your surgery, before the operation begins, you will have a Super-Resolution Ultrasound Localization Microscopy scan while you are asleep.
Compensation
Not stated in the trial record.
Follow-up
Your condition will be assessed from enrollment until your first follow-up visit about one month after your bladder removal surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06986304

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

Recruiting
Not specifiedAges 18+Observational
Duke University
~30 participants
Updated 2026-05-04 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Presence and stage of residual bladder cancer at the time of RC.
Measured over From enrollment to first post-cystectomy follow-up visit (1 month)
Bladder Cancer

NCT06986304

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Duke University

    Durham, North Carolinastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Michael Abern, M.D. · PRINCIPAL_INVESTIGATOR · Duke University

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Eligibility criteria

Inclusion

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

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.
  • 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.