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Phenotyping Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) by Intravesical Contrast Enhanced - Magnetic Resonance Imaging (ICE-MRI) Bladder Permeability Assay

NCT05811377 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2025-05-25

No results posted yet for this 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.

Conditions

  • IC - Interstitial Cystitis

Interventions

DRUG

Ferumoxytol

After fully emptying the bladder with a catheter,1.5mg of Ferumoxytol combined with Gadobutrol 302 mg will be instilled into the bladder through the catheter. The catheter will be plugged, and the patient will submit to an MRI scan of the bladder. After the MRI is completed, the Ferumoxytol will be drained through the catheter and the catheter will be removed.

DRUG

Gadobutrol

After fully emptying the bladder with a catheter, 302 mg of Gadobutrol (combined with Ferumoxytol) will be instilled into the bladder through the catheter. The catheter will be plugged, and the patient will submit to a MRI scan of the bladder. After the MRI is completed, the Gadobutrol will be drained through the catheter and the catheter will be removed.

Sponsors & Collaborators

  • Lipella Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • National Institutes of Health (NIH)

    collaborator NIH

  • Christopher J Chermansky, MD

    lead OTHER

Principal Investigators

  • Christopher Chermansky, MD · University of Pittsburgh

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-29
Primary Completion
2025-05-20
Completion
2025-05-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05811377 on ClinicalTrials.gov