Multi-parameter Magnetic Resonance Imaging for Early Evaluation of the Efficacy of Neoadjuvant Chemotherapy With Modified GC Regimen for Urothelial Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Changes from baseline tumor mp-MRI parameters at immediate mp-MRI evaluation.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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) ≥
- •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.)
研究组 & 干预措施
Experimental: Chemotherapy + mpMRI + surgery
Baseline mpMRI /Neoadjuvant chemotherapy /Immediate mpMRI /Cystectomy and Lymphadenectomy / Postoperative pathology
Drug: Chemotherapy Procedure: Immediate Multiparametric MRI Procedure: Cystectomy and Lymphadenectomy
干预措施: Chemotherapy (Drug)
Experimental: Chemotherapy + mpMRI + surgery
Baseline mpMRI /Neoadjuvant chemotherapy /Immediate mpMRI /Cystectomy and Lymphadenectomy / Postoperative pathology
Drug: Chemotherapy Procedure: Immediate Multiparametric MRI Procedure: Cystectomy and Lymphadenectomy
干预措施: Immediate Multiparametric MRI (Diagnostic Test)
Experimental: Chemotherapy + mpMRI + surgery
Baseline mpMRI /Neoadjuvant chemotherapy /Immediate mpMRI /Cystectomy and Lymphadenectomy / Postoperative pathology
Drug: Chemotherapy Procedure: Immediate Multiparametric MRI Procedure: Cystectomy and Lymphadenectomy
干预措施: Cystectomy and Lymphadenectomy (Procedure)
Experimental: Chemotherapy + mpMRI + surgery
Baseline mpMRI /Neoadjuvant chemotherapy /Immediate mpMRI /Cystectomy and Lymphadenectomy / Postoperative pathology
Drug: Chemotherapy Procedure: Immediate Multiparametric MRI Procedure: Cystectomy and Lymphadenectomy
干预措施: conventional Multiparametric MRI (Diagnostic Test)
Experimental: Chemotherapy + mpMRI + surgery
Baseline mpMRI /Neoadjuvant chemotherapy /Immediate mpMRI /Cystectomy and Lymphadenectomy / Postoperative pathology
Drug: Chemotherapy Procedure: Immediate Multiparametric MRI Procedure: Cystectomy and Lymphadenectomy
干预措施: Baseline Multiparametric MRI (Diagnostic Test)
Experimental: Chemotherapy + surgery
Baseline mpMRI /Neoadjuvant chemotherapy /Cystectomy and Lymphadenectomy / Postoperative pathology
Drug: Chemotherapy Procedure: Cystectomy and Lymphadenectomy
干预措施: Chemotherapy (Drug)
Experimental: Chemotherapy + surgery
Baseline mpMRI /Neoadjuvant chemotherapy /Cystectomy and Lymphadenectomy / Postoperative pathology
Drug: Chemotherapy Procedure: Cystectomy and Lymphadenectomy
干预措施: Cystectomy and Lymphadenectomy (Procedure)
Experimental: Chemotherapy + surgery
Baseline mpMRI /Neoadjuvant chemotherapy /Cystectomy and Lymphadenectomy / Postoperative pathology
Drug: Chemotherapy Procedure: Cystectomy and Lymphadenectomy
干预措施: conventional Multiparametric MRI (Diagnostic Test)
Experimental: Chemotherapy + surgery
Baseline mpMRI /Neoadjuvant chemotherapy /Cystectomy and Lymphadenectomy / Postoperative pathology
Drug: Chemotherapy Procedure: Cystectomy and Lymphadenectomy
干预措施: Baseline Multiparametric MRI (Diagnostic Test)
结局指标
主要结局
Changes from baseline tumor mp-MRI parameters at immediate mp-MRI evaluation.
时间窗: baseline, during the intervention (Within 24 hours after use of cisplatin of the first course of neoadjuvant chemotherapy(NAC), up to 2 weeks)
Using the built-in tools of the MRI imaging system to assess the changes of tumor size between immediate mp-MRI evaluation and baseline mp-MRI evaluation after the use of cisplatin during the first course of modified GC neoadjuvant chemotherapy.
次要结局
- Changes from baseline tumor mp-MRI parameters after two course of modified GC neoadjuvant chemotherapy.(baseline, during the intervention(From the end date of the second course of NAC until one day before the third course of NAC, up to 7 weeks))
- Changes from baseline tumor mp-MRI parameters after three course of modified GC neoadjuvant chemotherapy.(baseline, during the intervention(From the end date of the third course of NAC until one day before surgery, up to 10 weeks))