PurposeTo evaluate whether immediate multiparametric MRI evaluate the sensitivity of modified neoadjuvant chemotherapy early in patient with muscle invasive bladder cancerMIBC.
RationaleMultiparametric MRI may help detect the early changes of bladder cancer receiving neoadjuvant chemotherapy.
Objective
Primary: To evaluate whether multiparametric MRI can determine the sensitivity of modified neoadjuvant chemotherapy early in patient with muscle invasive bladder cancerMIBC.
SecondaryTo determine whether multiparametric MRI can predict the prognosis of modified neoadjuvant chemotherapy early in patient with muscle invasive bladder cancer.
Patients may receive neoadjuvant chemotherapy (typically three 21-day courses of modified gemcitabine-cisplatin(GC) therapy) followed by radical cystectomy and lymph node dissection.
Patients with primary bladder cancer or recurrence which is confirmed by pathology of previous biopsy or TURBT, undergo a multiparametric MRI(mpMRI) at baseline to stage the primary tumor. The mpMRI includes T2-weighted MRI, diffusion-weighted imaging, and dynamic contrast enhancement, which will be given a five-point VI-RADSVesical Imaging-Reporting And Data System score by two radiologists specialized in urogenital radiology. Patients considered NMIBCNon-muscle invasive bladder cancer with mpMRI will be given TURBT, while patients with MIBCMuscle invasive bladder cancerwill receive radical cystectomy and lymph node dissection after three 21-day courses of modified gemcitabine-cisplatin neoadjuvant chemotherapy. Patients also undergo an immediate mpMRI scan after one, two, and three cycles of neoadjuvant chemotherapy.
Specimens from the radical cystectomy are then examined by the pathology department as standard routine.
Condition | urinary tract neoplasm, Urologic Cancer, bladder cancer, bladder cancer, Bladder Carcinoma, Urothelial Cancer, bladder disorder, Bladder Disorders, Urothelial Cancer, Bladder Disorders, Bladder Carcinoma, Urologic Cancer, carcinoma of the bladder, bladder tumor |
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Treatment | Chemotherapy, Cystectomy and Lymphadenectomy, Immediate Multiparametric MRI, conventional Multiparametric MRI, Baseline Multiparametric MRI |
Clinical Study Identifier | NCT04588168 |
Sponsor | The First Affiliated Hospital with Nanjing Medical University |
Last Modified on | 26 January 2021 |
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