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).
調査の概要
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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Bordeaux、フランス、36076 Bordeaux cedex
- 募集
- CHU de Bordeaux - Hôpital Pellegrin - Service d'imagerie diagnostique et interventionnelle de l'adulte
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コンタクト：
- Nicolas GRENIER, MD, PhD
- 電話番号：+33 556 795 599
- メール：nicolas.grenier@chu-bordeaux.fr
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主任研究者：
- Nicolas GRENIER, MD, PhD
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Lyon、フランス、69003
- 募集
- Hospices Civils de Lyon - Hôpital Édouard Herriot
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コンタクト：
- Fanny CROS
- 電話番号：+33 (0)4 72 11 04 00
- メール：fanny.cros@chu-lyon.fr
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コンタクト：
- Olivier Rouvière, Pr
- 電話番号：+33 (0)4 72 11 09 51
- メール：olivier.rouviere@chu-lyon.Fr
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主任研究者：
- Olivier Rouvière, Pr
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Paris、フランス、75743 Paris cedex 15
- 募集
- Assistance Publique Hôpitaux de Paris - Hôpital Necker - Service de Radiologie adultes
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コンタクト：
- Jean-Michel CORREAS, MD, PhD
- 電話番号：+33 144 495 312
- メール：jean-michel.correas@nck.aphp.fr
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主任研究者：
- Jean-Michel CORREAS, MD, PhD
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：1
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Diagnostic performance (sensitivity and specificity) of the VueBoxTM-Prostate software in distinguishing prostate cancer from normal peripheral zone
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Diagnostic performance (sensitivity and specificity) of the VueBoxTM-Prostate software in distinguishing aggressive prostate cancer (Gleason score ≥7) from normal peripheral zone
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Olivier ROUVIERE, Professor、Hospices Civils de Lyon
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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