IC - Interstitial CystitisNCT05811377
Phenotyping Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) by Intravesical Contrast Enhanced - Magnetic Resonance Imaging (ICE-MRI) Bladder Permeability Assay
An observational study of IC - Interstitial Cystitis, run by Christopher J Chermansky, MD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- IC - Interstitial Cystitis
- What is being tested?
- Ferumoxytol and Gadobutrol
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2023to 20 May 2025
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 18-80 years old subjects from both genders and an IC/BPS diagnosis with a cystoscopic finding of Hunner lesions or absence
Who may be able to join
- 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:
- Pain (suprapubic, pelvic, urethral, vaginal or perineal) associated with bladder storage symptoms and pain on bladder filling that is relieved upon emptying
- Urgency or nocturia (average of >1 nocturnal void over 3 consecutive days on bladder diary). The O'Leary-Sant Interstitial cystitis symptom index (ICSI) and Interstitial cystitis problem index (ICPI) are valid and reliable measures of IC/BPS symptoms, and only IC/BPS patients with scores of ICSI of > 9 and an ICPI > 8 will be recruited.
- Age matched controls with no abnormal cystoscopic findings and with no bladder storage symptoms will be recruited.
Who cannot join
- Patients with urinary incontinence, suspicion for UTI on urine dipstick, history of recurrent UTIs, or history of spinal cord injury. Notwithstanding the fact that chronic bladder inflammation of IC/BPS patients evokes higher bladder permeability to instilled radiolabeled sodium chloride than acute inflammation of UTI patients, the investigators plan to exclude patients with UTIs as a confounding factor to rigorously establish the link between Hunner lesion and bladder permeability.
- Patients with current diagnosis or previous history of urologic malignancy, prior bladder augmentation surgery, pelvic radiation, serum creatinine >1.5mg/dl, diabetes mellitus, untreated hypertension, and proteinuria.
- Participants in whom magnetic resonance imaging (MRI) is contraindicated including, but not limited to, those with a pacemaker, presence of metallic fragments near the eyes or spinal cord, or cochlear implant, any other implanted MRI non-compatible device of any type (cardiac pacemaker, sacral neuromodulation device, and shunt)
- Patients who are claustrophobic, cannot sign informed consent, or have a past allergic reaction to either Gadobutrol or Ferumoxytol and any history of allergic reaction to any intravenous iron product.
- Women of child-bearing age who are pregnant or plan to become pregnant (urine pregnancy test will be performed for premenopausal women with no history of prior hysterectomy)
- Patients who cannot safely refrain from taking any analgesics or steroidal/non-steroidal anti-inflammatory or immunosuppressive drugs for one week preceding the MRI to avoid any confounding effect of anti-inflammatory drugs on bladder permeability.
- Any patient with a history of allergic reaction to any intravenous iron product.
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Magee Women's Hospital
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Phenotyping Interstitial Cystitis/Bladder Pain Syndrome by 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 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.
Read the detailed description
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.
- Conditions
- IC - Interstitial Cystitis
- Being tested
- Ferumoxytol, Gadobutrol
- Keywords
- IC - Interstitial Cystitis, Hunners Lesion
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FerumoxytolDiagnostic test
Also called Feraheme
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.
GadobutrolDiagnostic test
Also called Gadavist
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.
| Study group | Role | What they receive |
|---|---|---|
| Non-Hunner IC | Participants without a Hunner lesion on cystoscopy prior to ICE-MRI Receives: Diagnostic Test: Ferumoxytol; Diagnostic Test: Gadobutrol | |
| Hunner IC | Participants with a Hunner lesion on cystoscopy prior to ICE-MRI Receives: Diagnostic Test: Ferumoxytol; Diagnostic Test: Gadobutrol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 min image post-contrast
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start29 Mar 2023
- Primary completion7 Feb 2025
- Study completion20 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for IC - Interstitial CystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christopher J Chermansky, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Lipella Pharmaceuticals, Inc., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor-investigator, Christopher J Chermansky, MD, University of Pittsburgh
- Investigators
- Christopher Chermansky, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05811377
- Sponsor's protocol ID
- STUDY22030048
- Other IDs
- R44DK108397
- Status last verified
- Jul 2026
- First submitted
- 2 Nov 2022
- Last updated
- 10 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29392488Tyagi 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.
PubMed 30473772
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenotyping Interstitial Cystitis/Bladder Pain Syndrome by ICE-MRI Bladder Permeability Assay
- ClinicalTrials.gov ID
- NCT05811377
- Acronym / sponsor ID
- STUDY22030048
- Conditions
- IC - Interstitial Cystitis
- Keywords
- IC - Interstitial Cystitis, Hunners Lesion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Christopher J Chermansky, MDUniversity, hospital or other
- Collaborators
- Lipella Pharmaceuticals, Inc., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 29 Mar 2023 (actual)
- Primary completion
- 7 Feb 2025 (actual)
- Study completion
- 20 May 2025 (actual)
- First posted
- 13 Apr 2023 (actual)
- Results
- Posted 10 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Hunner IC | – | Diagnostic Test: Ferumoxytol, Diagnostic Test: GadobutrolParticipants without a Hunner lesion on cystoscopy prior to ICE-MRI |
| Hunner IC | – | Diagnostic Test: Ferumoxytol, Diagnostic Test: GadobutrolParticipants with a Hunner lesion on cystoscopy prior to ICE-MRI |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 18-80 years old subjects from both genders and an IC/BPS diagnosis with a cystoscopic finding of Hunner lesions or absence
Key inclusion criteria (4 listed)
- 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:
- Pain (suprapubic, pelvic, urethral, vaginal or perineal) associated with bladder storage symptoms and pain on bladder filling that is relieved upon emptying
- Urgency or nocturia (average of >1 nocturnal void over 3 consecutive days on bladder diary). The O'Leary-Sant Interstitial cystitis symptom index (ICSI) and Interstitial cystitis problem index (ICPI) are valid and reliable measures of IC/BPS symptoms, and only IC/BPS patients with scores of ICSI of > 9 and an ICPI > 8 will be recruited.
- Age matched controls with no abnormal cystoscopic findings and with no bladder storage symptoms will be recruited.
Key exclusion criteria (7 listed)
- Patients with urinary incontinence, suspicion for UTI on urine dipstick, history of recurrent UTIs, or history of spinal cord injury. Notwithstanding the fact that chronic bladder inflammation of IC/BPS patients evokes higher bladder permeability to instilled radiolabeled sodium chloride than acute inflammation of UTI patients, the investigators plan to exclude patients with UTIs as a confounding factor to rigorously establish the link between Hunner lesion and bladder permeability.
- Patients with current diagnosis or previous history of urologic malignancy, prior bladder augmentation surgery, pelvic radiation, serum creatinine >1.5mg/dl, diabetes mellitus, untreated hypertension, and proteinuria.
- Participants in whom magnetic resonance imaging (MRI) is contraindicated including, but not limited to, those with a pacemaker, presence of metallic fragments near the eyes or spinal cord, or cochlear implant, any other implanted MRI non-compatible device of any type (cardiac pacemaker, sacral neuromodulation device, and shunt)
- Patients who are claustrophobic, cannot sign informed consent, or have a past allergic reaction to either Gadobutrol or Ferumoxytol and any history of allergic reaction to any intravenous iron product.
- Women of child-bearing age who are pregnant or plan to become pregnant (urine pregnancy test will be performed for premenopausal women with no history of prior hysterectomy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FerumoxytolAlso: FerahemeAfter 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. | Diagnostic test | Hunner IC, Non-Hunner IC |
| GadobutrolAlso: GadavistAfter 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. | Diagnostic test | Hunner IC, Non-Hunner IC |
Primary outcome
Bladder Permeability
Time frame: 12 min image post-contrast
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29392488Tyagi 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.
- Background: PubMed 30473772Tyagi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Chermansky, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IC - Interstitial Cystitis, run by Christopher J Chermansky, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bladder Permeability (time frame: 12 min image post-contrast). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05811377, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.