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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

Must not have

History of recurrent UTIs

Diabetes mellitus

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

No Placebo-Only Group

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.

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.

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.

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I experience pain in my lower abdomen or pelvic area that gets better after I urinate.

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I often feel a sudden need to urinate or need to urinate more than once at night.

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I am healthy with no bladder issues or symptoms.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had multiple urinary tract infections.

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I have diabetes.

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I experience involuntary loss of urine.

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I am unable to give my consent for treatment.

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I have or had cancer in my urinary system.

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I have had a spinal cord injury.

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I have had surgery to make my bladder larger.

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I have received radiation therapy to my pelvis.

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I have high blood pressure that hasn't been treated.

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I am a woman who is pregnant or planning to become pregnant.

Timeline

Screening ~ 3 weeks3 visits

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~960