Recruiting

Ultrasound-Guided Biopsy

Sponsor:

Mayo Clinic

Code:

NCT07029256

Conditions

Bladder Urothelial Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Non-Interventional Study

Study Details

Brief summary:

This study is being done to test the feasibility and accuracy of using an ultrasound-guided core needle biopsy technique as a potential tool for staging urothelial carcinoma of the bladder (UCB).

Conditions

Bladder Urothelial Carcinoma

Study ID

NCT07029256

Start date

Jul 26, 2024

Status verified date

Jun, 2026

Completion date

Jul 30, 2030

Anticipated

Primary completion date

Jul 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Undergoing radical cystectomy for confirmed or suspected urothelial carcinoma of the bladder
  • Prior abdominal imaging

Exclusion Criteria:

  • History of partial cystectomy or complex bladder reconstruction or substitution (i.e. bladder augment or urothelial recurrence in a neobladder)

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational

Patients undergo standard of care radical cystectomy and residual tissues collected undergo US core needle biopsy. Additionally, patients have their medical records reviewed on study.

Interventions

Non-Interventional Study

Non-interventional study

Primary outcome measure

  • Concordance between US and core needle biopsy stage and final surgical specimen pathologic stage [ Time Frame: Baseline (after completion of bladder surgery) ]

Central Contacts and Locations

Central contacts

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Principal Investigator:

Vidit Sharma, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Jun 10, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-06-10.