NCT04369560 Virtual Histology of the Bladder Wall for Bladder Cancer Staging
| NCT ID | NCT04369560 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Jodi Maranchie |
| Condition | Urinary Bladder Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2025-05-23 |
| Primary Completion | 2028-01-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 42 participants in total. It began in 2025-05-23 with a primary completion date of 2028-01-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. 18 to 90 years of age 2. Able to understand and willing to sign a written informed consent document 3. 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. 4. Performance status of ECOG 0 or 1 5. 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. Exclusion Criteria: 1. Severe hypersensitivity reaction to gadobutrol or ferumoxytol. 2. Severe claustrophobia that will prevent completion of the MRI study. 3. Any MRI-non-compatible implanted device, prosthetic or pacemaker. 4. Known or suspected metastatic disease. 5. Women with active pregnancy, lactation or plans to conceive 6. Untreated urinary tract infection 7. Known urethral stricture disease that would prohibit placement of foley catheter. 8. Any other conditions considered as unacceptable risk by the treating physician
Contact & Investigator
Jodi K Maranchie, MD
PRINCIPAL INVESTIGATOR
Associate Professor
Frequently Asked Questions
Who can join the NCT04369560 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Urinary Bladder Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04369560 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04369560 currently recruiting?
Yes, NCT04369560 is actively recruiting participants. Contact the research team at rowlesbm@upmc.edu for enrollment information.
Where is the NCT04369560 trial being conducted?
This trial is being conducted at Pittsburgh, United States.
Who is sponsoring the NCT04369560 clinical trial?
NCT04369560 is sponsored by Jodi Maranchie. The principal investigator is Jodi K Maranchie, MD at Associate Professor. The trial plans to enroll 42 participants.