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

Nanjing Medical University

Status: Enrolling

Conditions: Bladder Cancer

Treatments: Diagnostic Test: Immediate Multiparametric MRI; Diagnostic Test: conventional Multiparametric MRI; Diagnostic Test: Baseline Multiparametric MRI; Procedure: Cystectomy and Lymphadenectomy; Drug: Chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04588168

2020-SR-252

Details and patient eligibility

About

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.

Full description

Objective

Primary: To evaluate whether multiparametric MRI can determine the sensitivity of modified neoadjuvant chemotherapy early in patient with muscle invasive bladder cancer（MIBC）.

Secondary：To 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-RADS（Vesical Imaging-Reporting And Data System） score by two radiologists specialized in urogenital radiology. Patients considered NMIBC（Non-muscle invasive bladder cancer） with mpMRI will be given TURBT, while patients with MIBC（Muscle invasive bladder cancer）will 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Experimental: Chemotherapy + mpMRI + surgery

Experimental group

Description:

Baseline mpMRI /Neoadjuvant chemotherapy /Immediate mpMRI /Cystectomy and Lymphadenectomy / Postoperative pathology Drug: Chemotherapy Procedure: Immediate Multiparametric MRI Procedure: Cystectomy and Lymphadenectomy

Treatment:

Drug: Chemotherapy

Diagnostic Test: Baseline Multiparametric MRI

Procedure: Cystectomy and Lymphadenectomy

Diagnostic Test: conventional Multiparametric MRI

Diagnostic Test: Immediate Multiparametric MRI

Experimental: Chemotherapy + surgery

Experimental group

Description:

Baseline mpMRI /Neoadjuvant chemotherapy /Cystectomy and Lymphadenectomy / Postoperative pathology Drug: Chemotherapy Procedure: Cystectomy and Lymphadenectomy

Treatment:

Drug: Chemotherapy

Diagnostic Test: Baseline Multiparametric MRI

Procedure: Cystectomy and Lymphadenectomy

Diagnostic Test: conventional Multiparametric MRI