Ultrasound-guided core needle biopsy to stage bladder urothelial carcinoma
Official title: Ultrasound-Guided Core Needle Biopsy to Stage Urothelial Carcinoma of the Bladder
Run by Mayo Clinic · NCT07029256 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Status | Recruiting |
| Started | July 26, 2024 |
| Main results expected | July 30, 2030 |
| Study ends | July 30, 2030 |
| Registry record updated | June 10, 2026 |
| Trial ID | NCT07029256 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
New combination therapy for HER2-positive muscle-invasive bladder cancer
A phase 2, multi-center study tests four sensitizing drugs with disitamab vedotin and toripalimab in adults with HER2-positive muscle-invasive bladder cancer to see if the treatment can lead to tumor reduction and potential bladder preservation.
-
Combining futibatinib and durvalumab before bladder cancer surgery for patients who can't use cisplatin
This study is testing if combining two drugs, futibatinib and durvalumab, before bladder cancer surgery can help patients who can't take cisplatin feel better and improve their chances of recovery.
-
Observing quality of life in patients after bladder cancer surgery
This study looks at how bladder cancer surgery affects the quality of life for patients over about 10 years by checking in with them each year.
-
Tracking quality of life and relapses in bladder cancer patients after surgery
This study is tracking how bladder cancer patients feel and whether their cancer comes back after surgery over the next 10 years.
-
Infusion of engineered lymphocytes for patients with NY-ESO-1 expressing metastatic cancers
This study is testing a new treatment using specially modified immune cells to see if it can help people with certain advanced cancers that have the NY-ESO-1 marker.
-
Chemotherapy before surgery for upper tract urothelial cancer
This study is testing if giving chemotherapy before surgery helps people with upper tract urothelial cancer live longer compared to the usual treatment of surgery followed by chemotherapy.
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.