Does Neoadjuvant Chemotherapy Affect the Accuracy of Magnetic Resonance Imaging Before Radical Cystectomy? A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Compare the accuracy of MRI between patients who received and those who didn't receive NAC
研究概览
简要总结
The goal of this clinical trial is to learn if neoadjuvant chemotherapy (NAC) affects the accuracy of magnetic resonance imaging (MRI) in staging muscle-invasive bladder cancer (MIBC). This study will also assess how tissue changes induced by NAC impact MRI interpretation. The main questions it aims to answer are:
Does NAC compromise the accuracy of MRI in staging MIBC?
Does NAC-induced tissue change affect the reliability of MRI in tumor assessment?
Researchers will compare MRI staging accuracy in MIBC patients who received NAC to those who went directly to surgery, to see if NAC impacts MRI's diagnostic performance.
Participants will:
Undergo MRI scanning before surgery
Receive either NAC or go directly to surgery, depending on their group assignment
Have their MRI results compared to histopathological outcomes after surgery
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
- •Patients diagnosed with cT2 urothelial carcinoma of the urinary bladder, according to the TNM classification, who give informed, written consent on participation in the study and approve all its requirements.
排除标准
- •Patients who have received pelvic radiotherapy.
- •Previous open or laparoscopic pelvic surgery.
- •Patients with contraindications to MRI.
- •Patients who are unfit for or refuse radical cystectomy.
- •Ineligibility to cisplatin.
- •squamous differentiation in the histopathology
研究组 & 干预措施
Neoadjuvant Chemotherapy Arm
Participants in this arm will receive standard-of-care neoadjuvant chemotherapy (NAC) before undergoing radical cystectomy for muscle-invasive bladder cancer (MIBC). MRI will be performed post-NAC for local tumor restaging, and the results will be compared to histopathology to evaluate the diagnostic accuracy of MRI.
干预措施: Neoadjuvant Chemotherapy (Drug)
Neoadjuvant Chemotherapy Arm
Participants in this arm will receive standard-of-care neoadjuvant chemotherapy (NAC) before undergoing radical cystectomy for muscle-invasive bladder cancer (MIBC). MRI will be performed post-NAC for local tumor restaging, and the results will be compared to histopathology to evaluate the diagnostic accuracy of MRI.
干预措施: Radical Cystectomy (Procedure)
Radical cystectomy-Only arm
Participants in this arm will undergo immediate radical cystectomy without receiving neoadjuvant chemotherapy. MRI will be performed preoperatively for local tumor staging, and results will be compared with post-surgical histopathology to assess the accuracy of MRI in this setting.
干预措施: Radical Cystectomy (Procedure)
结局指标
主要结局
Compare the accuracy of MRI between patients who received and those who didn't receive NAC
时间窗: At the time of radical cystectomy and final histopathology report (approximately 3 to 6 months after starting NAC)
This outcome aims to evaluate and compare the diagnostic accuracy of MRI in detecting tumor stage in bladder cancer patients who underwent NAC prior to radical cystectomy versus those who did not receive NAC.
次要结局
未报告次要终点
研究者
Amr Esam Saad Mohamed Darwish
Lecturer
Assiut University