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NCT05811377 · ClinicalTrials.gov registry record · Early Phase 1
Phenotyping Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) by Intravesical Contrast Enhanced - Magnetic Resonance Imaging (ICE-MRI) Bladder Permeability Assay
A Early Phase 1 study of IC - Interstitial Cystitis, sponsored by Christopher J Chermansky, MD.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 8
- Enrollment target
- 1
- Study location
NCT05811377: Completed Early Phase 1 study of IC - Interstitial Cystitis, sponsored by Christopher J Chermansky, MD.
NCT05811377 is a Early Phase 1 study of IC - Interstitial Cystitis that has completed, run by Christopher J Chermansky, MD. The registered enrollment target is 8 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05811377, a Early Phase 1 study of IC - Interstitial Cystitis, has completed, sponsored by Christopher J Chermansky, MD.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 8 participants
- Enrollment target
- 1
- Study location
Study Summary
Each participant will be asked to participate in this research study which distinguishes different types of Interstitial Cystitis/Bladder Pain Syndrome. Research studies include only people who wish to participate. The study team members will explain the study to each participant, and all questions about the study will be answered. Each participant will be given adequate time when deciding to participate in this study. Should the participant consent to participate, then the participant will agree to undergo have a single Magnetic Resonance Imaging (MRI) test that involves the use of radio waves and a powerful magnet which are linked to a computer that looks at the bladder. The MRI test is being performed to see if the bladder is leaky, which would suggest Interstitial Cystitis (IC). The MRI test involves placing Gadobutrol and Ferumoxytol into the bladder using a sterile catheter, a small hollow tube through which fluids pass. Preliminary data suggests that IC patients with Hunners lesions have increased Gadobutrol in the bladder wall lining.
Primary Outcome
Changes in bladder permeability were demonstrated by increased or decreased absorption of the contrast- Gadobutrol. This was measured in artificial units through signal intensity. Increased absorption was shown with brighter color in the bladder wall (associated with higher artificial unit values), while less absorption was demonstrated with darker color (associated with lower artificial unit values). Elevated absorption of instilled Gadobutrol into bladder wall was assessed with the darker appe
Conditions Studied
Interventions
- DRUG Ferumoxytol
- DRUG Gadobutrol
Study Locations (1)
Pennsylvania
- UPMC Magee Women's Hospital - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2023-03-29 |
| Est. Completion | 2025-05-20 |
| Phase | Early Phase 1 |
What the finished NCT05811377 record still lists
NCT05811377 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (85% lower).
The record links to 1 condition, with IC - Interstitial Cystitis appearing as the primary indexed condition, and to 2 interventions - of which Ferumoxytol is the first listed.
NCT05811377 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05811377 about?
NCT05811377 is a clinical study titled "Phenotyping Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) by Intravesical Contrast Enhanced - Magnetic Resonance Imaging (ICE-MRI) Bladder Permeability Assay". Each participant will be asked to participate in this research study which distinguishes different types of Interstitial Cystitis/Bladder Pain Syndrome. Research studies include only people who wish to participate. The study team members will explain the study to each participant, and all questions ...
What is the current status of trial NCT05811377?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 8 participants. The study started on 2023-03-29. Estimated completion is 2025-05-20.
What conditions does trial NCT05811377 study?
This clinical trial studies the following conditions: IC - Interstitial Cystitis.
What interventions are being tested in trial NCT05811377?
The interventions under investigation include: Ferumoxytol (DRUG), Gadobutrol (DRUG).
Who is sponsoring clinical trial NCT05811377?
This trial is sponsored by Christopher J Chermansky, MD, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05811377 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
How this trial's enrollment target compares
Where NCT05811377's enrollment target sits among peer trials
8 1783rd of 2000 higher than 176 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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