Quantitative Prostate Cancer Contrast-enhanced Ultrasound (SONOCAP)
Background: Bracco has released the VueBoxTM-Prostate software, aimed at distinguishing prostate cancer from prostate benign peripheral zone (PZ) at contrast-enhanced ultrasound (CEUS) using SonoVue® as contrast agent.
The software analyses the ascending phase of enhancement (wash-in) and calculates the mode and the dispersion (sigma) of the wash-in rate in a given region of interest. The diagnosis of cancer is based on the combination of these two parameters.
The main objective of the study is to evaluate the diagnostic value of the VueBoxTM-Prostate software in distinguishing prostate cancer from normal PZ at contrast-enhanced ultrasound (CEUS).
The secondary objective is to evaluate the diagnostic value of the wash-out rate, the time to peak, the transit time and the area under the enhancement curve (parameters not used by the VueBoxTM-Prostate software) in distinguishing prostate cancer from prostate benign peripheral zone at contrast-enhanced ultrasound (CEUS).
The study will enroll patients referred for prostate biopsy. The US transrectal probe will be inserted and the local anesthesia performed as per the institution's standard of care protocol. Then, the biopsy operator will choose an axial plane likely to contain cancer (e.g. based on MRI or Digital rectal examination results). Half a vial (2.4 ml) of SonoVue® will then be injected and the ultrasound enhancement of this plane will be recorded during 2 minutes while the biopsy gun is already in place. Then, the biopsy will be taken while the recording is still on, so that it will be possible to calculate quantitative enhancement parameters at the exact location of the biopsy.
Then, the operator will choose a plane that is likely not to contain cancer in the opposite prostate lobe and the same process will be repeated with injection of the second half of the vial.
The rest of the biopsies will be performed as per the institution's standard of care protocol.
The two recordings will be sent to Bracco's Research center in Geneva in order to:
- Predict the biopsy result (cancer vs benign) based on the VueBoxTM-Prostate software results
- Calculate the wash-out rate, the time to peak, the transit time and the area under the enhancement curve at the biopsy location.
The two biopsy samples performed after the injection of SonoVue® (as the rest of the biopsy samples) will be processed and analysed at the institution's department of Pathology and their results will be blinded to the Bracco's Research center.
The correlation between the biopsy results, the VueBoxTM-Prostate software results and the wash-out rate, time to peak, transit time and area under the enhancement curve will be performed by the study investigator.
In total, 130 patients will be included (hypotheses of 20% of malignant biopsy cores and of an area under the ROC curve of 0.85 for the VueBoxTM-Prostate software).
研究概览
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Bordeaux、法国、36076 Bordeaux cedex
- 招聘中
- CHU de Bordeaux - Hôpital Pellegrin - Service d'imagerie diagnostique et interventionnelle de l'adulte
-
接触：
- Nicolas GRENIER, MD, PhD
- 电话号码：+33 556 795 599
- 邮箱：nicolas.grenier@chu-bordeaux.fr
-
首席研究员：
- Nicolas GRENIER, MD, PhD
-
Lyon、法国、69003
- 招聘中
- Hospices Civils de Lyon - Hôpital Édouard Herriot
-
接触：
- Fanny CROS
- 电话号码：+33 (0)4 72 11 04 00
- 邮箱：fanny.cros@chu-lyon.fr
-
接触：
- Olivier Rouvière, Pr
- 电话号码：+33 (0)4 72 11 09 51
- 邮箱：olivier.rouviere@chu-lyon.Fr
-
首席研究员：
- Olivier Rouvière, Pr
-
Paris、法国、75743 Paris cedex 15
- 招聘中
- Assistance Publique Hôpitaux de Paris - Hôpital Necker - Service de Radiologie adultes
-
接触：
- Jean-Michel CORREAS, MD, PhD
- 电话号码：+33 144 495 312
- 邮箱：jean-michel.correas@nck.aphp.fr
-
首席研究员：
- Jean-Michel CORREAS, MD, PhD
-
-
参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patient referred for prostate biopsy
- Informed consent signed
- Patient affiliated to the French Health Insurance
Exclusion Criteria:
- History of allergy to SonoVue®
- History of myocardial infarction or angor pectoris
- History of severe pulmonary arterial hypertension (> 90 mm Hg)
- History of previous treatment for prostate cancer (radiation therapy, brachytherapy, high-intensity focused ultrasound, etc…)
- History of hormone therapy for prostate cancer
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：1个
|
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 performance (sensitivity and specificity) of the VueBoxTM-Prostate software in distinguishing prostate cancer from normal peripheral zone
大体时间：Day 1
|
Using as a reference the result of the biopsy sample performed after the SonoVue® injection and the location of which will have been strictly monitored
|
Day 1
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Diagnostic performance (sensitivity and specificity) of the VueBoxTM-Prostate software in distinguishing aggressive prostate cancer (Gleason score ≥7) from normal peripheral zone
大体时间：Day 1
|
using as a reference the result of the biopsy sample performed after the SonoVue® injection and the location of which will have been strictly monitored
|
Day 1
|
|
Diagnostic performance (sensitivity and specificity) of the of the wash-out rate, time to peak, transit time and area under the enhancement curve in distinguishing prostate cancer from normal peripheral zone
大体时间：Day 1
|
using as a reference the result of the biopsy sample performed after the SonoVue® injection and the location of which will have been strictly monitored
|
Day 1
|
|
Diagnostic performance (sensitivity and specificity) of the of the wash-out rate, time to peak, transit time and area under the enhancement curve in distinguishing aggressive prostate cancer (Gleason score ≥7) prostate cancer from normal peripheral zone
大体时间：Day 1
|
using as a reference the result of the biopsy sample performed after the SonoVue® injection and the location of which will have been strictly monitored
|
Day 1
|
合作者和调查者
调查人员
- 首席研究员：Olivier ROUVIERE, Professor、Hospices Civils de Lyon
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
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
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