NCT06986304 Characterizing the Microvascular Environment of Bladder Cancer With Super-Resolution Ultrasound Localization Microscopy
| NCT ID | NCT06986304 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Duke University |
| Condition | Bladder Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-10-28 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2025-10-28 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Michael Abern, M.D.
PRINCIPAL INVESTIGATOR
Duke University
Frequently Asked Questions
Who can join the NCT06986304 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bladder Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06986304 currently recruiting?
Yes, NCT06986304 is actively recruiting participants. Contact the research team at michael.abern@duke.edu for enrollment information.
Where is the NCT06986304 trial being conducted?
This trial is being conducted at Durham, United States.
Who is sponsoring the NCT06986304 clinical trial?
NCT06986304 is sponsored by Duke University. The principal investigator is Michael Abern, M.D. at Duke University. The trial plans to enroll 30 participants.
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