Virtual Histology of the Bladder Wall for Bladder Cancer Staging
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|ClinicalTrials.gov Identifier: NCT04369560|
Recruitment Status : Recruiting
First Posted : April 30, 2020
Last Update Posted : September 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|Urinary Bladder Neoplasms||Diagnostic Test: Magnetic Resonance Imaging Drug: Gadobutrol intravesical administration (4mM) Drug: Ferumoxytol intravesical administration (5 mM)||Early Phase 1|
Twenty one patients with at least one cystoscopically confirmed papillary bladder tumor, who have been scheduled for Transurethral Resection of Bladder Tumor (TURBT) for surgical extirpation and staging, and twenty-one patients with histologically confirmed, muscle invasive transitional cell carcinoma of the bladder who have been scheduled for definitive radical cystectomy with curative intent will be recruited for a single study Magnetic Resonance Imaging to be performed between 1 and 6 days prior to their scheduled procedure.
Magnetic Resonance Imaging of all the enrolled patients will be performed on a 60-cm, wide-bore, 3T scanner (Siemens AG, Erlangen, Germany) with a 32-channel pelvic phased-array coil placed over the bladder using radial k-space sampling technique for volumetric free breathing acquisition with NCM enhanced StarVIBE57. Un-enhanced fast spoiled gradient-echo images with fat suppression will be obtained prior aseptic instillation of 50cc of a novel contrast mixture (NCM) of Gadobutrol (4 mM) plus Ferumoxytol (5 mM) in sterile water through a temporary urethral catheter. The catheter will then be removed and the patient repositioned in the scanner to obtain post-contrast images. All the image datasets will be linearly registered to the subject to ensure that regions of interest represent the same anatomical location at all time points. Post-contrast T1, pre-contrast T1 and deltaT1 will be measured from the acquired images. Two radiologists blinded to the pathologic findings will evaluate the Magnetic Resonance images to assign a radiologic tumor stage that will be compared with the subsequent pathologic stage determined at time of surgery. Following the MRI study, subjects will proceed with their surgical procedure as scheduled per standard of care.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Diagnostic Test - Magnetic Resonance Imaging|
|Masking:||None (Open Label)|
|Official Title:||Virtual Histology of the Bladder Wall for Bladder Cancer Staging; A Novel Intravesical Contrast-Enhanced MRI for Bladder Cancer Staging|
|Estimated Study Start Date :||September 2020|
|Estimated Primary Completion Date :||September 2022|
|Estimated Study Completion Date :||December 2022|
Experimental: Magnetic Resonance Imaging
Prior to planned surgical resection, subjects 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 50mL solution containing Gadobutrol (4 mM) plus ferumoxytol (5 mM) and a second, single breath hold post-contrast image.
Diagnostic Test: Magnetic Resonance Imaging
60-cm wide bore 3T scanner (Siemens AG, Erlangen, Germany) with a 32-channel pelvic phased-array coil placed over the bladder.
Drug: Gadobutrol intravesical administration (4mM)
A paramagnetic macrocyclic gadolinium-based contrast agent administered intravenously for use in magnetic resonance imaging. Contrast-enhancement is a result of the neutral complex of gadolinium and dihydroxy-hydroxymethylpropyl- tetraazacyclododecane-triacetic acid (butrol).
Other Name: Image result for other names for Gadobutrol Gadavist
Drug: Ferumoxytol intravesical administration (5 mM)
An iron preparation (Fe3O4) approved for intravenous treatment of anemia in the setting of renal failure, comprised of superparamagnetic iron oxide nanoparticles which are coated by a semi-synthetic carbohydrate shell in an isotonic, neutral pH solution.
Other Name: FERAHEME
- Accuracy of Magnetic Resonance Imaging assessment of depth of bladder wall penetration to predict pathologic stage determined at tumor resection [ Time Frame: 4 weeks ]The assessment of clinical tumor stage assigned by the radiologist will be compared to the stage reported by the clinical pathologist following tumor resection to determine the overall accuracy of MRI for bladder cancer staging.
- Accuracy of Magnetic Resonance Imaging to detect residual/recurrent bladder tumor [ Time Frame: 4 weeks ]Patients are typically scheduled for radical cystectomy after initial TURBT with or without neoadjuvant chemotherapy. MRI findings of bladder tumor will be compared with the areas of tumor identified on whole mount sectioning of the bladder to estimate the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of MRI for bladder cancer. Receiver operating characteristic (ROC) curve analysis will be used to estimate the tumor size threshold value for the diagnosis with MRI.
- Rate of Adverse Events [ Time Frame: 2 years ]Characterize the safety profile of MRI imaging following direct bladder instillation of a mixture of Gadobutrol and Ferumoxytrol (50mL in sterile water) via urethral catheter by soliciting and recording adverse events while on study.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04369560
|Contact: Dawn McBride, RNemail@example.com|
|United States, Pennsylvania|
|UPMC Department of Urology||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15232|
|Contact: Joseph Craig, RN 412-623-2764 firstname.lastname@example.org|
|Principal Investigator:||Jodi K Maranchie, MD||Associate Professor|