Comparison of CT and MR (VI-RADS) Imaging for Local Bladder Cancer Staging
Prospective Diagnostic Accuracy Study Comparing CT and MRI (VI-RADS) for Local Staging of Newly Diagnosed Bladder Cancer
研究概览
地位
详细说明
Accurate local staging is crucial for distinguishing non-muscle-invasive from muscle-invasive bladder cancer and guiding treatment decisions. While CT is widely used in clinical practice, MRI with VI-RADS has demonstrated higher diagnostic performance in previous retrospective and meta-analytic studies. However, prospective paired comparisons in the same patients are limited.
In this single-center prospective study, newly diagnosed bladder cancer patients undergo cystoscopy, contrast-enhanced CT, and multiparametric MRI prior to definitive histopathological sampling. Two radiologists independently assess imaging in a blinded research setting. Diagnostic performance of MRI and CT is compared using paired statistical analyses, with additional evaluation of interobserver agreement and tumor characteristics.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Study Coordinator, Department of Urology
- 电话号码：+47 22 89 40 00
- 邮箱：postmottak@ous-hf.no
学习地点
-
-
-
Oslo、挪威
- 招聘中
- Oslo University Hospital
-
接触：
- Study Coordinator, Department of Urology
- 电话号码：+47 22 89 40 00
- 邮箱：postmottak@ous-hf.no
-
首席研究员：
- Andreas Habberstad, MD, PhD
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
The study population consists of adult patients with newly diagnosed bladder cancer identified on cystoscopy at a tertiary referral hospital. Eligible participants are patients planned for transurethral resection of the bladder tumor (TURBT) and/or cystectomy as part of standard clinical care, and who are able to undergo both contrast-enhanced computed tomography (CT) and multiparametric magnetic resonance imaging (MRI) prior to definitive histopathological assessment.
Patients are included irrespective of tumor stage or grade at presentation, provided that imaging is performed within the defined preoperative diagnostic pathway. Patients with prior bladder cancer treatment or contraindications to imaging are excluded.
描述
Inclusion Criteria:
- Age ≥ 18 years
- Newly diagnosed bladder cancer on cystoscopy
- Planned TURBT or cystectomy within 6 weeks
- Eligible for both CT and MRI within 6 weeks
- Written informed consent provided
Exclusion Criteria:
- Contraindications to MRI or iodinated contrast media
- Prior treatment for bladder cancer
- Pregnancy
- Non-malignant bladder lesions
- Tumors located in bladder diverticula
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
|
Imaging Comparison Group
All participants undergo contrast-enhanced CT and multiparametric MRI (VI-RADS) as part of routine diagnostic work-up prior to transurethral resection of the bladder tumor or cystectomy.
Imaging findings are compared with histopathology for assessment of diagnostic accuracy.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Diagnostic Accuracy for Detection of Muscle-Invasive Bladder Cancer (≥T2)
大体时间：From imaging to final histopathological reference standard (up to 12 months)
|
The primary outcome is the diagnostic accuracy of multiparametric magnetic resonance imaging (MRI) using the Vesical Imaging-Reporting and Data System (VI-RADS) compared with contrast-enhanced computed tomography (CT) for the detection of muscle-invasive bladder cancer (pathological stage ≥T2).
Sensitivity and specificity will be calculated using histopathology from transurethral resection of the bladder tumor, re-TURBT, and/or cystectomy as the reference standard.
|
From imaging to final histopathological reference standard (up to 12 months)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Positive and Negative Predictive Values
大体时间：From imaging to final histopathological reference standard (up to 12 months)
|
Positive predictive value (PPV) and negative predictive value (NPV) of MRI (VI-RADS) and CT for detection of muscle-invasive bladder cancer (≥T2), calculated using histopathology as the reference standard.
|
From imaging to final histopathological reference standard (up to 12 months)
|
|
Interobserver Agreement for MRI and CT Tumor Staging
大体时间：During blinded image evaluation following imaging acquisition
|
Interobserver agreement between two independent radiologists for MRI VI-RADS scoring and CT-based T-stage assessment, quantified using weighted kappa statistics in a blinded research reading setting.
|
During blinded image evaluation following imaging acquisition
|
|
Proportion of correctly classified Tumor T-stage (Ta-T4) by MRI and CT
大体时间：From imaging to final histopathological reference standard (up to 12 months)
|
Proportion of correctly classified tumor T-stage (Ta-T4) by MRI and CT compared with histopathological staging from TURBT and/or cystectomy.
|
From imaging to final histopathological reference standard (up to 12 months)
|
|
Diagnostic accuracy of MRI and CT for detection of muscle-invasive bladder cancer within tumor subgroups
大体时间：From imaging to final histopathological reference standard (up to 12 months)
|
Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of MRI and CT for detection of muscle-invasive bladder cancer, assessed within predefined tumor subgroups (tumor size, morphology, tumor location and multiplicity), using histopathology as the reference standard.
|
From imaging to final histopathological reference standard (up to 12 months)
|
合作者和调查者
调查人员
- 首席研究员：Andreas Habberstad, MD, PhD、Oslo University Hospital
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- 970903
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.