Magnetic Resonance Imaging as a Comprehensive Staging Tool for the Evaluation of High-Risk Prostate Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Accuracy of whole body magnetic resonance imaging (MRI)
研究概览
简要总结
This trial studies how well magnetic resonance whole body diffusion-weighted imaging works in finding cancer that has spread to the bone or lymph nodes (metastasis) in participants with high-risk prostate cancer. Diagnostic procedures, such as magnetic resonance whole body diffusion-weighted imaging (a method to show how water moves in a certain area) may help find bone or lymph nodes metastasis.
详细描述
PRIMARY OBJECTIVES:
I. To compare accuracies of whole body magnetic resonance imaging (MRI) versus bone scan plus computed tomography (CT) scan in detecting bone or lymph node metastasis in high risk prostate cancer patients.
OUTLINE:
Participants undergo standard of care bone scan, CT of the abdomen and pelvis, and pelvic MRI. Participants also undergo magnetic resonance whole body (WB)-diffusion-weighted imaging (DWI) over 20-30 minutes.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Prostate carcinoma patients at high risk for metastasis with prostate-specific antigen (PSA) more than 20 ng/ml and/or Gleason score = 8/ >
- •Ability to understand and sign informed consent.
排除标准
- •Patient is at low risk for metastasis with Gleason score at diagnosis <
- •Currently receiving or history of systemic therapy with testosterone suppressing medication (i.e., lupron, degarelix, abiraterone, enzalutamide) or local radiation therapy.
- •Contraindication to magnetic resonance imaging (MRI).
研究组 & 干预措施
Diagnostic (bone scan, CT, MRI, magnetic resonance WB-DWI)
Participants undergo standard of care bone scan, CT of the abdomen and pelvis, and pelvic MRI. Participants also undergo magnetic resonance WB-DWI over 20-30 minutes.
干预措施: Bone Scan (Procedure)
Diagnostic (bone scan, CT, MRI, magnetic resonance WB-DWI)
Participants undergo standard of care bone scan, CT of the abdomen and pelvis, and pelvic MRI. Participants also undergo magnetic resonance WB-DWI over 20-30 minutes.
干预措施: Computed Tomography (Procedure)
Diagnostic (bone scan, CT, MRI, magnetic resonance WB-DWI)
Participants undergo standard of care bone scan, CT of the abdomen and pelvis, and pelvic MRI. Participants also undergo magnetic resonance WB-DWI over 20-30 minutes.
干预措施: Magnetic Resonance Imaging (Procedure)
Diagnostic (bone scan, CT, MRI, magnetic resonance WB-DWI)
Participants undergo standard of care bone scan, CT of the abdomen and pelvis, and pelvic MRI. Participants also undergo magnetic resonance WB-DWI over 20-30 minutes.
干预措施: Magnetic Resonance Whole Body Diffusion-Weighted Imaging (Procedure)
结局指标
主要结局
Accuracy of whole body magnetic resonance imaging (MRI)
时间窗: Up to 6 months
Accuracy will be estimated along with 95% confidence intervals for whole body MRI (for bone and lymph node metastasis), bone scan (for bone metastasis), and computed tomography (CT) scan (for lymph node metastasis). Comparisons between modalities will be performed using McNemar's test. Other statistical analyses will be carried out as appropriate.
次要结局
- Sensitivity of MRI, bone scan, and CT scan(Up to 9 years)
- Positive predictive value (PPV) of MRI, bone scan, and CT scan(Up to 9 years)
- Negative predictive value (NPV) of MRI, bone scan, and CT scan(Up to 9 years)
- Detection of other types of metastases(Up to 9 years)
- Specificity of MRI, bone scan, and CT scan(Up to 9 years)