NCT04369560RecruitingEarly phase 1
Virtual Histology of the Bladder Wall for Bladder Cancer Staging
Virtual Histology of the Bladder Wall for Bladder Cancer Staging; A Novel Intravesical Contrast-Enhanced MRI for Bladder Cancer Staging
Source: ClinicalTrials.gov · Last updated 17 Dec 2025
Brief summary (registry, in English)
This is a phase Ib study of the safety and performance of a novel intravesical contrast-enhanced Magnetic Resonance Imaging protocol for determination of bladder cancer stage prior to transurethral resection of bladder tumor (21 subjects) or prior to radical cystectomy for muscle invasive disease (21 subjects). Subjects will undergo a single MRI study: a pre-contrast, single breath hold image followed by sterile placement of a temporary urethral catheter for instillation of a 50mL solution containing Gadobutrol (4 mM) plus ferumoxytol (5 mM) and then a second, post-contrast image. Images will be reviewed by two dedicated abdominal radiologists, who are blinded to the pathologic staging, for determination of tumor presence and depth of bladder wall penetration.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 42 (estimated)
- First submitted
- 27 Apr 2020
- Start date
- 23 May 2025
- Primary completion date
- 30 Jan 2028
- Lead sponsor
- Jodi Maranchie
- Diseases
- Bladder cancer
- NCT number
- NCT04369560
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 42
- From 23 May 2025 to the primary completion date, 30 Jan 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Severe hypersensitivity reaction to gadobutrol or ferumoxytol.
- Known or suspected metastatic disease.
- Untreated urinary tract infection
- Known urethral stricture disease that would prohibit placement of foley catheter.
- Any other conditions considered as unacceptable risk by the treating physician
Other
- Severe claustrophobia that will prevent completion of the MRI study.
- Any MRI-non-compatible implanted device, prosthetic or pacemaker.
- Women with active pregnancy, lactation or plans to conceive
Who the study is looking for
- 18 to 90 years of age
- Able to understand and willing to sign a written informed consent document
- A papillary tumor identified by cystoscopy that has been scheduled for TURBT OR histologically proven MIBC that is clinically localized and amenable to surgical resection with curative intent.
- Performance status of ECOG 0 or 1
- Normal renal function as defined as creatinine less than 1.5 x institutional upper limit of normal (ULN) OR creatinine clearance greater than or equal to 50 mL/min/1.73 m2 by Cockcroft-Gault formula for subjects with creatinine levels greater than or equal to 1.5 x ULN.
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UPMC Hillman Cancer Center - Dept of Urology Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.