Urinary Bladder Neoplasms Clinical Trial
Official title:
Virtual Histology of the Bladder Wall for Bladder Cancer Staging; A Novel Intravesical Contrast-Enhanced MRI for Bladder Cancer Staging
This is a phase Ib study of the safety and performance of a novel intravesical contrast-enhanced Magnetic Resonance Imaging protocol for determination of bladder cancer stage prior to transurethral resection of bladder tumor (21 subjects) or prior to radical cystectomy for muscle invasive disease (21 subjects). Subjects will undergo a single MRI study: a pre-contrast, single breath hold 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 then a second, post-contrast image. Images will be reviewed by two dedicated abdominal radiologists, who are blinded to the pathologic staging, for determination of tumor presence and depth of bladder wall penetration.
Status | Recruiting |
Enrollment | 42 |
Est. completion date | December 2024 |
Est. primary completion date | September 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: 1. 18 to 90 years of age 2. Able to understand and willing to sign a written informed consent document 3. A papillary tumor identified by cystoscopy that has been scheduled for TURBT OR histologically proven MIBC that is clinically localized and amenable to surgical resection with curative intent. 4. Performance status of ECOG 0 or 1 5. Normal renal function as defined as creatinine less than 1.5 x institutional upper limit of normal (ULN) OR creatinine clearance greater than or equal to 50 mL/min/1.73 m2 by Cockcroft-Gault formula for subjects with creatinine levels greater than or equal to 1.5 x ULN. Exclusion Criteria: 1. Severe hypersensitivity reaction to gadobutrol or ferumoxytol. 2. Severe claustrophobia that will prevent completion of the MRI study. 3. Any MRI-non-compatible implanted device, prosthetic or pacemaker. 4. Known or suspected metastatic disease. 5. Women with active pregnancy, lactation or plans to conceive 6. Untreated urinary tract infection 7. Known urethral stricture disease that would prohibit placement of foley catheter. 8. Any other conditions considered as unacceptable risk by the treating physician |
Country | Name | City | State |
---|---|---|---|
United States | UPMC Department of Urology | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Jodi Maranchie | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Accuracy of Magnetic Resonance Imaging assessment of depth of bladder wall penetration to predict pathologic stage determined at tumor resection | 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. | 4 weeks | |
Secondary | Accuracy of Magnetic Resonance Imaging to detect residual/recurrent bladder tumor | 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. | 4 weeks | |
Secondary | Rate of Adverse Events | 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. | 2 years |
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