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| ID | Type | Description | Link |
|---|---|---|---|
| R44DK108397 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Lipella Pharmaceuticals, Inc. | INDUSTRY |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
Visit 1 and Visit 2 (for cystoscopy if not recently performed): Potential subjects seen in the clinic as part of routine clinical care that meet inclusion and exclusion criteria will only participate in the study. Urine pregnancy test (if childbearing potential) and dip Urinalysis (UA) test (to screen for UTI) will be done on visit 1. Many of the patients screened for this study will have already had cystoscopy performed within the last 6 months as this is done to determine if patients have either Hunners lesion IC (HIC) or non-Hunners lesion IC (NHIC). Patients who have had a recent cystoscopy won't need repeat cystoscopy done during a second visit; however, if no cystoscopy has been performed within the past 6 months, cystoscopy will be performed on a second visit within 2-4 weeks of visit 1. Dip UA test (to screen for UTI) will be done on visit 2 prior to cystoscopy for those participants who have not had cystoscopy within the last 6 months. Asymptomatic control patients will need cystoscopy during visit 2 if no prior cystoscopy has been performed within the past 6 months. Thus, all participants will submit to visit 1 for screening and signing of informed consent. Visit 2 for cystoscopy will only be necessary for those patients who have not had cystoscopy performed within 6 months of completing informed consent on visit 1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-Hunner IC | Participants without a Hunner lesion on cystoscopy prior to ICE-MRI |
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| Hunner IC | Participants with a Hunner lesion on cystoscopy prior to ICE-MRI |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferumoxytol | Diagnostic Test | After fully emptying the bladder with a catheter, 0.1mM Ferumoxytol combined with Gadobutrol 20mM 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Bladder Permeability | 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 appearance of the bladder center. | 12 min image post-contrast |
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Inclusion Criteria:
18-80 years old subjects from both genders and an IC/BPS diagnosis with a cystoscopic finding of Hunner lesions or absence and also have the following:
Age matched controls with no abnormal cystoscopic findings and with no bladder storage symptoms will be recruited.
Exclusion Criteria:
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18-80 years old subjects from both genders and an IC/BPS diagnosis with a cystoscopic finding of Hunner lesions or absence
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Chermansky, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Magee Women's Hospital | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29392488 | Background | Tyagi P, Janicki J, Moon CH, Kaufman J, Chermansky C. Novel contrast mixture achieves contrast resolution of human bladder wall suitable for T1 mapping: applications in interstitial cystitis and beyond. Int Urol Nephrol. 2018 Mar;50(3):401-409. doi: 10.1007/s11255-018-1794-0. Epub 2018 Feb 1. | |
| 30473772 | Background | Tyagi P, Moon CH, Janicki J, Kaufman J, Chancellor M, Yoshimura N, Chermansky C. Recent advances in imaging and understanding interstitial cystitis. F1000Res. 2018 Nov 9;7:F1000 Faculty Rev-1771. doi: 10.12688/f1000research.16096.1. eCollection 2018. |
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The study team was unable to recruit any asymptomatic control participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Non-Hunner IC | Participants who did not show Hunner lesion on cystoscopy performed prior to MRI |
| FG001 | Hunner IC | Participants who showed Hunner lesions on cystoscopy before MRI |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 20, 2025 |
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| Gadobutrol | Diagnostic Test | After fully emptying the bladder with a catheter, 20mM 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. |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Non Hunner IC | Participants Without Hunner Lesion on cystoscopy performed prior to ICE-MRI |
| BG001 | Participants With Hunner Lesion | Participants with Hunner Lesion on cystoscopy performed prior to ICE-MRI |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Bladder Permeability | 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 appearance of the bladder center. | Posted | Mean | Standard Deviation | artificial units | 12 min image post-contrast |
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24 hours after MRI test
Patient advised to call Research Coordinator at any time after MRII
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Non-Hunner IC | IC/BPS patients who did not show Hunner lesion on cystoscopy | 0 | 5 | 0 | 5 | 0 | 5 |
| EG001 | Hunner IC | IC/BPS patients with Hunner lesion on cystoscopy | 0 | 2 | 0 | 2 | 0 | 2 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vickie Polanco-garcia | Department of Urology, University of Pittsburgh School of Medicine | 412-641-1364 | polancogarciav@upmc.edu |
| Jul 9, 2026 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 15, 2022 | Nov 25, 2022 | ICF_000.pdf |
| ID | Term |
|---|---|
| D018856 | Cystitis, Interstitial |
| ID | Term |
|---|---|
| D003556 | Cystitis |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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