Ultrasound-guided core needle biopsy to stage bladder urothelial carcinoma
Ultrasound-Guided Core Needle Biopsy to Stage Urothelial Carcinoma of the Bladder
This will try whether an ultrasound-guided core needle biopsy can accurately stage bladder urothelial carcinoma in people scheduled for radical cystectomy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT07029256 on ClinicalTrials.gov |
What this trial studies
This is an observational feasibility study in which patients scheduled for radical cystectomy undergo an ultrasound-guided core needle biopsy of the bladder tumor prior to surgery. Biopsy specimens are processed and interpreted by pathology and compared with the final surgical pathology from the cystectomy to determine concordance in stage and sampling adequacy. The study will record procedure feasibility, diagnostic yield, and any immediate complications related to the biopsy. Conducted at Mayo Clinic in Rochester, the protocol uses prior abdominal imaging to guide biopsy planning and targeting.
Who should consider this trial
Good fit: Ideal candidates are people with confirmed or suspected urothelial carcinoma of the bladder who are scheduled for radical cystectomy and have prior abdominal imaging.
Not a fit: Patients with prior partial cystectomy, complex bladder reconstruction (including neobladder), tumors not accessible to ultrasound-guided biopsy, or those not undergoing cystectomy are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, this technique could provide more accurate preoperative staging to better guide treatment planning and avoid under- or overtreatment.
How similar studies have performed: Image-guided percutaneous biopsies have been used in small series for genitourinary tumors, but application of ultrasound-guided core needle biopsy specifically for bladder cancer staging is relatively novel with limited prior data.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Vidit Sharma, MD — Mayo Clinic in Rochester
- Study coordinator: Hosanna Yeadon, BA
- Email: biffert.hosanna@mayo.edu
- Phone: 507-538-5019
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.