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Ferumoxytol · 1 trial · 1 indication
The MRI bladder permeability assay that will be tested involves instilling Gadobutrol and Ferumoxytol into the bladder through a urethral catheter. Then, with both contrast agents in the bladder, T1 MRI weighted images will be obtained and the bladder wall permeability will be calculated.
| Arm | Type | Description |
|---|---|---|
| ICE-MRI | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| Ferumoxytol | DRUG | 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. |
| Gadobutrol | DRUG | 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. |
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: 1. Pain (suprapubic, pelvic, urethral, vaginal or perineal) associated with bladder storage symptoms and pain on bladder filli...
Ferumoxytol is being studied for use in interstitial cystitis, also known as bladder pain syndrome. It is administered intravesically, meaning directly into the bladder, as part of a contrast-enhanced MRI procedure to assess bladder permeability. The drug is currently in early Phase 1 clinical development for this condition.
Ferumoxytol is an iron oxide nanoparticle that acts as a contrast agent for magnetic resonance imaging. In the context of interstitial cystitis, it is used to enhance MRI imaging to evaluate bladder permeability. The drug does not target a specific molecular pathway but rather serves as an imaging agent to visualize bladder wall characteristics.
Lipella Pharmaceuticals Inc. (NASDAQ: LIPO) is developing Ferumoxytol for interstitial cystitis. The company is conducting clinical research to evaluate the drug's use as an intravesical contrast agent for MRI-based bladder permeability assessment in patients with this condition.
Ferumoxytol is in early Phase 1 clinical development for interstitial cystitis. A clinical trial with the identifier NCT05811377 has been completed, involving 8 participants. The study was an uncontrolled, non-randomized trial conducted in the United States, and it included healthy volunteers as well as patients with the condition.
Ferumoxytol has been studied in one clinical trial for interstitial cystitis, registered as NCT05811377. The trial was titled 'Phenotyping Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) by Intravesical Contrast Enhanced - Magnetic Resonance Imaging (ICE-MRI) Bladder Permeability Assay.' It was an early Phase 1 study that has been completed, with a total enrollment of 8 participants.
Ferumoxytol is a specific iron oxide nanoparticle contrast agent used for MRI. It is distinct from gadolinium-based contrast agents commonly used in MRI. In the context of interstitial cystitis research, Ferumoxytol is administered intravesically to assess bladder permeability, a unique application compared to its more common intravenous use in other imaging procedures.