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NCT04369560 · ClinicalTrials.gov registry record · Early Phase 1
Virtual Histology of the Bladder Wall for Bladder Cancer Staging
A Early Phase 1 study of Urinary Bladder Neoplasms, sponsored by Jodi Maranchie.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 42
- Enrollment target
- 1
- Study location
NCT04369560: Recruiting Early Phase 1 study of Urinary Bladder Neoplasms, sponsored by Jodi Maranchie.
NCT04369560 is a Early Phase 1 study of Urinary Bladder Neoplasms that is actively recruiting participants, run by Jodi Maranchie. The registered enrollment target is 42 participants, below the 311-participant average among 19 other Urinary Bladder Neoplasms trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04369560, a Early Phase 1 study of Urinary Bladder Neoplasms, is actively recruiting participants, sponsored by Jodi Maranchie.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 42 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The assessment of clinical tumor stage assigned by the radiologist will be compared to the stage reported by the clinical pathologist following tumor resection to determine the overall accuracy of MRI for bladder cancer staging.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Magnetic Resonance Imaging
- DRUG Gadobutrol intravesical administration (4mM)
- DRUG Ferumoxytol intravesical administration (5 mM)
Study Locations (1)
Pennsylvania
- UPMC Hillman Cancer Center - Dept of Urology - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2025-05-23 |
| Est. Completion | 2028-12-30 |
| Phase | Early Phase 1 |
What NCT04369560 shows while recruiting
NCT04369560 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 311-participant average among 19 other Urinary Bladder Neoplasms trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Urinary Bladder Neoplasms appearing as the primary indexed condition, and to 3 interventions - of which Magnetic Resonance Imaging is the first listed.
NCT04369560 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04369560 about?
NCT04369560 is a clinical study titled "Virtual Histology of the Bladder Wall for Bladder Cancer Staging". 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 (2...
What is the current status of trial NCT04369560?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 42 participants. The study started on 2025-05-23. Estimated completion is 2028-12-30.
What conditions does trial NCT04369560 study?
This clinical trial studies the following conditions: Urinary Bladder Neoplasms.
What interventions are being tested in trial NCT04369560?
The interventions under investigation include: Magnetic Resonance Imaging (DIAGNOSTIC_TEST), Gadobutrol intravesical administration (4mM) (DRUG), Ferumoxytol intravesical administration (5 mM) (DRUG).
Who is sponsoring clinical trial NCT04369560?
This trial is sponsored by Jodi Maranchie, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04369560 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04369560's enrollment target sits among peer trials
42 17th of 19 higher than 3 of 19 other Urinary Bladder Neoplasms trials
participants (enrollment target), bucketed by value
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