RECRUITINGINTERVENTIONAL

Multi-parameter Magnetic Resonance Imaging Guides Precise Treatment of Urothelial Carcinoma

Multi-parameter Magnetic Resonance Imaging for Early Evaluation of the Efficacy of Neoadjuvant Chemotherapy With Modified GC Regimen for Urothelial Carcinoma

About This Trial

Purpose：To evaluate whether immediate multiparametric MRI evaluate the sensitivity of modified neoadjuvant chemotherapy early in patient with muscle invasive bladder cancer（MIBC）. Rationale：Multiparametric MRI may help detect the early changes of bladder cancer receiving neoadjuvant chemotherapy.

Who May Be Eligible (Plain English)

Who May Qualify: - Pathologically confirmed primary or recurrent bladder cancer. - Planned to undergo transurethral resection of bladder tumor (TURBT) or modified GC regimen neoadjuvant chemotherapy plus radical total cystectomy. - 18 years old and older. - Willing to give valid written willing to sign a consent form. - No contraindications to the MRI(magnetic resonance imaging) and MRI contrast agent. Who Should NOT Join This Trial: - Abnormal liver function (1.5 times higher than normal). - Glomerular filtration rate \< 60ml /min·kg. - Heart failure. - Acute myocardial infarction. - Severe heart and lung disease. - Hypotension and hypoxia. - Brain metastases, or other known cancer that has spread to the brain. - A history of severe central nervous system diseases, including unexplained loss of consciousness or transient ischemic attack. - Known congenital or acquired weakened immune system, active hepatitis, active tuberculosis and other active infections, etc. - Pregnant or lactating women. - Patients participating in other drug trials. - Patients with poor general condition (eg malnutrition, dehydration). Behavioral status score (ZPS quintile) ≥ 2. - Patients with previous autoimmune conditions (where your immune system attacks your own body)s or existing autoimmune conditions (where your immune system attacks your own body)s. (including controlled or uncontrolled drugs). - Patients undergoing organ transplantation (transplantation of liver, kidney, heart, lung and other organs) or those who require long-term administration of immunosuppressive agents due to personal conditions. - Those who are intolerant or allergic to cytotoxic chemotherapeutic drugs. - Bone marrow transplantation, severe leukopenia. - Patients with severe infection or trauma. - Any condition based on the investigation's clinical judgment that the patient is not suitable for completing this study (such as not meeting the patient's most beneficial treatment, patient compliance, etc.) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Pathologically confirmed primary or recurrent bladder cancer. * Planned to undergo transurethral resection of bladder tumor (TURBT) or modified GC regimen neoadjuvant chemotherapy plus radical total cystectomy. * 18 years old and older. * Willing to give valid written informed consent. * No contraindications to the MRI(magnetic resonance imaging) and MRI contrast agent. Exclusion Criteria: * Abnormal liver function (1.5 times higher than normal). * Glomerular filtration rate \< 60ml /min·kg. * Heart failure. * Acute myocardial infarction. * Severe heart and lung disease. * Hypotension and hypoxia. * Brain metastases, or other known central nervous system metastases. * A history of severe central nervous system diseases, including unexplained loss of consciousness or transient ischemic attack. * Known congenital or acquired immunodeficiency, active hepatitis, active tuberculosis and other active infections, etc. * Pregnant or lactating women. * Patients participating in other drug trials. * Patients with poor general condition (eg malnutrition, dehydration). Behavioral status score (ZPS quintile) ≥ 2. * Patients with previous autoimmune diseases or existing autoimmune diseases. (including controlled or uncontrolled drugs). * Patients undergoing organ transplantation (transplantation of liver, kidney, heart, lung and other organs) or those who require long-term administration of immunosuppressive agents due to personal conditions. * Those who are intolerant or allergic to cytotoxic chemotherapeutic drugs. * Bone marrow transplantation, severe leukopenia. * Patients with severe infection or trauma. * Any condition based on the investigation's clinical judgment that the patient is not suitable for completing this study (such as not meeting the patient's most beneficial treatment, patient compliance, etc.)

Treatments Being Tested

DRUG

Chemotherapy

Patients with muscle invasive bladder cancer will receive modified gemcitabine-cisplatin neoadjuvant chemotherapy prior to radical cystectomy for a period of two months (three 21 day cycles) as part of standard clinical routine.

DIAGNOSTIC_TEST

Immediate Multiparametric MRI

Within 24 hours after the use of cisplatin during the first course of modified GC neoadjuvant chemotherapy, patient considered muscle invasive bladder cancer with baseline mpMRI will receive an immediate mpMRI scan.

PROCEDURE

Cystectomy and Lymphadenectomy

The patient with muscle invasive bladder cancer will undergo radical cystectomy and pelvic lymph node dissection followed by a urinary tract reconstruction.

DIAGNOSTIC_TEST

conventional Multiparametric MRI

After two and three course of neoadjuvant chemotherapy, patient considered muscle invasive bladder cancer with baseline mpMRI will receive a conventional mpMRI scan.

DIAGNOSTIC_TEST

Baseline Multiparametric MRI

Patient considered muscle invasive bladder cancer will receive a baseline mpMRI scan within one week before neoadjuvant chemotherapy.

Locations (1)

The first affiliated hospital of Nanjing Medical University

Nanjing, Jiangsu, China