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ICE-MRI Bladder Permeability Assay for Interstitial Cystitis

Phase < 1
Recruiting
Led By Christopher Chermansky, MD
Research Sponsored by Christopher J Chermansky, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18-80 years old subjects from both genders with an IC/BPS diagnosis and cystoscopic finding of Hunner lesions or absence
Pain (suprapubic, pelvic, urethral, vaginal or perineal) associated with bladder storage symptoms and pain on bladder filling that is relieved upon emptying
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the bladder permeability assay will be calculated immediately after the participant completes the mri imaging of the bladder with the instilled contrast agents, an exam that typically takes the participant 90 minutes to complete.
Awards & highlights

Study Summary

This trial studies if MRI scans can distinguish different types of Interstitial Cystitis/Bladder Pain Syndrome. Participants will be given an MRI test with radio waves and a powerful magnet to look at the bladder. They will also have a sterile catheter placed in the bladder with fluids to help with the MRI.

Who is the study for?
This trial is for adults aged 18-80 with Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS), experiencing pain related to bladder filling and relief upon emptying. It includes those with Hunner lesions or without, and control subjects without cystoscopic abnormalities. Excluded are individuals with urinary issues like incontinence, UTI history, spinal cord injury, urologic cancer history, certain surgeries or treatments, high creatinine levels, diabetes, untreated hypertension, proteinuria; also excluded are those who can't have an MRI due to metal implants or claustrophobia.Check my eligibility
What is being tested?
The study tests the use of ICE-MRI Bladder Permeability Assay using Gadobutrol and Ferumoxytol to identify leakiness in the bladder wall lining which may indicate IC/BPS. Participants will undergo a single MRI scan where these substances are introduced into the bladder via catheter to assess differences between types of IC/BPS.See study design
What are the potential side effects?
Potential side effects include allergic reactions to Gadobutrol or Ferumoxytol used during the MRI test. Other risks involve typical MRI-related concerns such as discomfort from lying still during the procedure and issues related to claustrophobia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 80 years old and have been diagnosed with IC/BPS, with or without Hunner lesions.
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I experience pain in my lower abdomen or pelvic area that gets better after I urinate.
Select...
I experience pain in my lower abdomen or pelvic area that gets better after I urinate.
Select...
I often feel a sudden need to urinate or need to urinate more than once at night.
Select...
I am healthy with no bladder issues or symptoms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the bladder permeability assay will be calculated immediately after the participant completes the mri imaging of the bladder with the instilled contrast agents, an exam that typically takes the participant 90 minutes to complete.
This trial's timeline: 3 weeks for screening, Varies for treatment, and the bladder permeability assay will be calculated immediately after the participant completes the mri imaging of the bladder with the instilled contrast agents, an exam that typically takes the participant 90 minutes to complete. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The bladder permeability will be measured using the MRI bladder permeability assay, and the differences between patients with Hunners Interstitial Cystitis (HIC), Non-Hunners Interstitial Cystitis (NHIC), and controls with no symptoms will be noted.

Trial Design

1Treatment groups
Experimental Treatment
Group I: ICE-MRIExperimental Treatment2 Interventions
Participants will undergo a single Magnetic Resonance Imaging study: a single breath-hold pre-contrast image followed by sterile placement of a temporary urethral catheter for instillation of a 50 milliliter (mL) solution containing Gadobutrol (302mg) plus ferumoxytol (5 mM) and a second, single breath hold post-contrast image.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ferumoxytol
2011
Completed Phase 4
~4380
Gadobutrol
2020
Completed Phase 3
~250

Find a Location

Who is running the clinical trial?

Christopher J Chermansky, MDLead Sponsor
1 Previous Clinical Trials
44 Total Patients Enrolled
Lipella Pharmaceuticals, Inc.Industry Sponsor
3 Previous Clinical Trials
58 Total Patients Enrolled
1 Trials studying Interstitial Cystitis
21 Patients Enrolled for Interstitial Cystitis
National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,820 Total Patients Enrolled

Media Library

ICE-MRI Clinical Trial Eligibility Overview. Trial Name: NCT05811377 — Phase < 1
Interstitial Cystitis Research Study Groups: ICE-MRI
Interstitial Cystitis Clinical Trial 2023: ICE-MRI Highlights & Side Effects. Trial Name: NCT05811377 — Phase < 1
ICE-MRI 2023 Treatment Timeline for Medical Study. Trial Name: NCT05811377 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I meet the requirements for participation in this medical research?

"For consideration in this medical trial, subjects must have interstitial cystitis and be between 18 to 80 years old. There are 30 available spots for the study."

Answered by AI

Is this experimental endeavor accepting individuals aged over fifty-five?

"The requirements for enrolment in this medical trial necessitate that the patient is between 18 to 80 years of age. Furthermore, there are 5 studies available for minors and 41 treatments designed with senior citizens in mind."

Answered by AI

Are fresh participants still being admitted to the trial?

"The availability of this clinical trial is documented on the official website, showing that it was first posted 4/28/2023 and has been recently updated on 4/10/2023. It currently requires participants to take part in the study."

Answered by AI

What is the sample size of participants in this experiment?

"Affirmative. Clinicaltrials.gov's records demonstrate that this clinical trial is still searching for participants and was first published on April 28th, 2023 before being updated lastly on April 10th of the same year. The medical research is looking to recruit 30 patients from one clinic location."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
What site did they apply to?
UPMC Magee Women's Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Phenotyping Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) by Intravesical Contrast Enhanced - Magnetic Resonance Imaging (ICE-MRI) Bladder Permeability Assay
Christopher J Chermansky, MD 2023. "Phenotyping Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) by Intravesical Contrast Enhanced - Magnetic Resonance Imaging (ICE-MRI) Bladder Permeability Assay". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05811377.
All > Interstitial Cystitis
~8 spots leftby Oct 2024
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