A Study Of Endoscopic Bladder Ultrasound And Core Needle Biopsy

Overview

About this study

The purpose of this study is to determine if endoscopic ultrasound with core needle biopsy of a bladder tumor can improve the clinical staging of bladder cancer.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

General Inclusion Criteria:

  • Adults over the age of 18

  • Ability to engage in the informed consent process or have an appropriate representative available to do so

  • All prior therapies allowed (NAC, XRT, intravesical treatment, etc.)

  • Caprini Risk Score ≤10 (to account for subtracting the active index bladder cancer being treated)

 

ARM A-TURBT Arm

  • Suspected or known de novo tumor of the bladder based on cystoscopy and/or imaging

  • Planned to undergo TURBT for a de novo bladder tumor 

  • Individuals who have a history of NMIBC with now a new tumor that has not been addressed yet (TURBT or biopsy) are eligible

 

ARM B-Radical Cystectomy Arm-Prior Systemic Therapy

  • Suspected or known tumor of the bladder based on cystoscopy, imaging, prior procedures and tissue sampling

  • Planned to undergo radical cystectomy for treatment of bladder cancer

  • History of (some) prior systemic therapy for bladder cancer-this includes traditional chemotherapy and/or treatments such as immunotherapy or antibody drug conjugates

  • Intravesical treatments for bladder cancer only do not qualify patients for this arm

 

ARM C-Radical Cystectomy Arm-No Prior Systemic Therapy

  • Suspected or known tumor of the bladder based on cystoscopy, imaging, prior procedures and tissue sampling

  • Planned to undergo radical cystectomy for treatment of bladder cancer

  • No history of (any) prior systemic therapy for bladder cancer-patients who have received intravesical treatments for bladder cancer only are eligible for this arm though

General Exclusion Criteria:

  • Inability to provide informed consent or an individual from a vulnerable population

  • Anatomic alteration or pathology that prevents retrograde access to bladder with bronchoscope (ex. closed bladder neck)

  • Prior major bladder reconstruction that alters the native makeup of the bladder wall such as in enteric bladder augmentation

  • Caprini Risk score of > 11

    • Prescreening

    • And allowing screen fail-out at time of surgery (after POE)

  • Active urinary tract infection not including suspected colonization

  • If the patient is such a poor general anesthetic (GA) candidate that they require spinal anesthesia, then they would not qualify for this study

  • Any significant medical history that would pose an unreasonable risk for TUR or make the subject unsuitable for the study

  • Subject is considered vulnerable such as incarcerated or cognitively impaired

 

ARM A-TURBT Arm

  • Prior resection of the tumor in question (i.e. not a de novo tumor)

  • Prior systemic therapy or radiation for bladder cancer

 

ARM B-Radical Cystectomy Arm-Prior Systemic Therapy

  • Radical cystectomy as part of other operation or not for a bladder cancer primary (known prior to surgery)

  • No prior systemic therapy for bladder cancer (see arm C)

 

ARM C-Radical Cystectomy Arm-No Prior Systemic Therapy

  • Radical cystectomy as part of other operation or not for a bladder cancer primary (known prior to surgery)

  • Prior systemic therapy for bladder cancer (see arm B)

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 03/18/2026. Questions regarding updates should be directed to the study team contact.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Vidit Sharma, M.D.

Contact us for the latest status

Contact information:

Kerry Peterson

5072930168

peterson.kerry@mayo.edu

More information

Publications

Publications are currently not available