Mapping bladder cancer blood vessels with super-resolution ultrasound
Official title: Characterizing the Microvascular Environment of Bladder Cancer With Super-Resolution Ultrasound Localization Microscopy
Run by Duke University · NCT06986304 · Data updated 2026-11-12
We will test whether a new super-resolution ultrasound performed right before bladder removal can detect remaining bladder cancer in adults having cystectomy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Status | Recruiting |
| Started | October 28, 2025 |
| Main results expected | January 2027 |
| Study ends | April 2027 |
| Registry record updated | May 4, 2026 |
| Trial ID | NCT06986304 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults over 18 with histologically confirmed urothelial bladder cancer for whom radical cystectomy is recommended, including muscle-invasive disease or select high-risk non–muscle-invasive cases, are eligible.
✕Probably not a fit
People who are pregnant or breastfeeding, have known allergies to sulfur hexafluoride lipid microsphere or PEG, had severe allergic reactions to COVID-19 vaccination, or who are acutely unstable or hospitalized in ICU are excluded and unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational project will enroll 30 adults with confirmed urothelial bladder cancer who are scheduled for radical cystectomy. After consent the team will collect basic clinical and surgical history, then perform a novel super-resolution ultrasound (ultrasound localization microscopy) after anesthesia and before the operation begins. The investigational ultrasound images will be compared with final surgical pathology and any prior imaging to see how well the technique identifies tumor-related microvascular changes. No experimental treatment is given; the procedure uses approved ultrasound contrast agents with specific exclusions for certain allergies.
Why it matters
Potential benefit: If successful, this imaging approach could improve detection of residual bladder tumor at the time of surgery and guide future imaging use.
How similar studies have gone: Microvascular ultrasound and contrast-enhanced ultrasound techniques have shown promise in cancer imaging, but super-resolution ultrasound localization microscopy is a newer approach with limited prior clinical validation for bladder cancer.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Duke University
Durham, North Carolina, United States Recruiting
Study contacts
- Principal investigator: Michael Abern, M.D. — Duke University
- Study coordinator: Michael Abern, M.D.
- Email: michael.abern@duke.edu
- Phone: 919-684-5057
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.