Comprehensive Multiparametric Magnetic Resonance Imaging After Transurethral Resection of Non Muscle-invasive Bladder Tumor; Can it Replace Second Look Biopsy? A Prospective Study
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- assessment of the performance of mpMRI as a diagnostic tool for possible residual malignancy after initial TURBT
研究概览
简要总结
The aim of the study is to prospectively assess the role of mpMRI as a non invasive method for assessment of possible residual tumor after initial resection of non muscle invasive bladder tumor.
详细描述
Comprehensive multiparametric (mp) MRI which includes T2 weighted imaging, dynamic contrast enhanced (DCE) imaging and DWI, was proven to be efficient tool in differentiating benign and malignant bladder lesion. morphological characterization of malignant bladder lesion (mapping/size/morphology/stalk), T stage differentiation and histological grade discrimination.
The application of mpMRI in NMIBC with its added value as non invasive tool for initial staging and after primary resection could be a new helpful method for better diagnosis, risk categorization, refining the indications of second resection and proper determination of adjuvant treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Ability to give informed consent.
- •Patients with primary or recurrent papillary NMIBC.
- •Normal cardiac, hematological, and renal functions.
排除标准
- •Patients with history of previous radiotherapy or systemic chemotherapy.
- •Patients suffering from immuno-deficiency or other malignancies.
- •Patients with high serum creatinine (more than 2 mg/dl).
- •Patients with contraindication to MRI (claustrophobia-pacemaker- metallic prosthesis).
研究组 & 干预措施
NMIBC patients
eligible patients will undergo initial mpMRI before initial TURBT, then followed by second mpMRI and second resection TURBT after 4 weeks
干预措施: mpMRI (Device)
NMIBC patients
eligible patients will undergo initial mpMRI before initial TURBT, then followed by second mpMRI and second resection TURBT after 4 weeks
干预措施: Second look TURBT (Procedure)
结局指标
主要结局
assessment of the performance of mpMRI as a diagnostic tool for possible residual malignancy after initial TURBT
时间窗: 1 year
assessment of the performance of mpMRI as a diagnostic tool for possible residual malignancy after initial TURBT by comparing the results obtained by pre-second look TURBT mpMRI (Test of the study) with results of second look biopsy whether benign or malignant (Standard test).
次要结局
- Predictive capability of initial mpMRI of differentiation between benign and malignant bladder lesions.(1 year)
- 2- Predictive capability of initial mpMRI of differentiation between NMIBC and muscle invasive disease.(1 year)
- Accuracy of bladder mapping in initial mpMRI (18) as a guide during TURBT.(1 year)
- Cost comparison of mpMRI and second look TURBT.(1 year)
- Predictive value of initial mpMRI for characterization of NMIBC (T stage, Grading, Risk categorization).(1 year)
- Rate of over staging and under staging of NMIBC after second look TURBT in this prospective series.(1 year)
- Morbidity (using modified Dindo-Clavian system for post-operative complications (19) and mortality rates after second look TURBT.(1 year)
- Readmission rate after second look TURBT.(1 year)
研究者
Amr Abdel-Lateif El-Sawy
Principal Investigator
Mansoura University