Noninvasive Detection of Clinically Occult Lymph Node Metastases in Prostate and Bladder Cancer Evaluated by USPIO-Enhanced MRI and Diffusion-Weighted MRI: A Histopathological Correlation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Discrimination of N positive (N+) vs. N negative (N0) patients (prostate and bladder cancer) using diffusion-weighted imaging, USPIO enhancement and both.
研究概览
简要总结
Preoperative detection of lymph node metastases in patients with prostate or bladder cancer is crucial for selection of the appropriate treatment strategy (surgery, androgen deprivation with/or without radiation therapy or chemotherapy) and thus for patient prognosis. Until now CT or MRI have been the modalities of choice for preoperative staging procedures. However, current morphological assessment of lymph nodes based on size and shape is unable to detect smaller metastases or liable to give false positive results on lymph nodes with reactive hyperplasia. We hypothesize that USPIO-enhanced MRI combined with DW-MRI will be able to detect pelvic lymph node metastases preoperatively with high sensitivity and specificity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically proven prostate cancer (T1-2N0M0 Gleason score 6-10) scheduled for radical prostatectomy or patients with histologically proven bladder cancer (T1-3bN0M0G3) scheduled for cystectomy
- •Written informed consent to participate in this trial.
排除标准
- •Patients with contraindications for MRI (e.g. pacemaker, metal implants, claustrophobia).
- •Patients in a critical cardiovascular state, with risk of decompensation after administration of the USPIO contrast agent.
- •Patients with hemochromatosis or an allergy to dextran or iron compounds.
- •Pregnant or breast-feeding women.
- •Patients who have received gadolinium complexes within 2 days or iron oxide particles within 7 days before MRI.
- •Patients who underwent chemotherapy or radiotherapy before surgery.
- •Patients whose degree of cooperation is incompatible with carrying out the study.
- •Patients with contraindications to Glucagon administration.
结局指标
主要结局
Discrimination of N positive (N+) vs. N negative (N0) patients (prostate and bladder cancer) using diffusion-weighted imaging, USPIO enhancement and both.
时间窗: 1 year
Preoperative localization of all suspected positive nodes in accordance to the predefined regions on both sides and in comparison with histopathology.
时间窗: 1 year
次要结局
- Node-by-node analysis of USPIO-enhanced and DW-MRI positive lymph nodes with histopathology.(2-3 years)