Informations générales (source: ClinicalTrials.gov)
(SONOCAP)
Interventional
N/A
Hospices Civils de Lyon (Voir sur ClinicalTrials)
juin 2015
juin 2020
29 juin 2024
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).
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Necker-Enfants Malades | Jean-Michel CORREAS, MD, PhD | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Hospices Civils de Lyon - Hopital Edouard Herriot - 69003 - Lyon - France | Olivier Rouvière, Pr | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU de Bordeaux - Hôpital Pellegrin - Service d'imagerie diagnostique et interventionnelle de l'adulte - 36076 Bordeaux cedex - Bordeaux - France | Nicolas GRENIER, MD, PhD | Contact (sur clinicalTrials) | |||
Critères
Homme
Inclusion Criteria:
- Patient referred for prostate biopsy
- Informed consent signed
- Patient affiliated to the French Health Insurance
- Patient referred for prostate biopsy
- Informed consent signed
- Patient affiliated to the French Health Insurance
- 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