NCT02295449

Brief Summary

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for not_applicable prostate-cancer

Timeline
Completed

Started Jun 2015

Typical duration for not_applicable prostate-cancer

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 20, 2014

Completed
7 months until next milestone

Study Start

First participant enrolled

June 9, 2015

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

August 31, 2018

Status Verified

August 1, 2018

Enrollment Period

5 years

First QC Date

November 17, 2014

Last Update Submit

August 29, 2018

Conditions

Prostate Cancer

Keywords

Prostate cancerContrast-enhanced ultrasound

Outcome Measures

Primary Outcomes (1)

  • Diagnostic performance (sensitivity and specificity) of the VueBoxTM-Prostate software in distinguishing prostate cancer from normal peripheral zone

    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

Secondary Outcomes (3)

  • Diagnostic performance (sensitivity and specificity) of the VueBoxTM-Prostate software in distinguishing aggressive prostate cancer (Gleason score ≥7) from normal peripheral zone

    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

    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

    Day 1

Study Arms (1)

1

EXPERIMENTAL
Device: biopsy sample performed after the SonoVue® injection

Interventions

biopsy sample performed after the SonoVue® injectionDEVICE
1

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patient referred for prostate biopsy
  • Informed consent signed
  • Patient affiliated to the French Health Insurance

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CHU de Bordeaux - Hôpital Pellegrin - Service d'imagerie diagnostique et interventionnelle de l'adulte

Bordeaux, 36076 Bordeaux cedex, France

RECRUITING

Hospices Civils de Lyon - Hopital Edouard Herriot

Lyon, 69003, France

RECRUITING

Assistance Publique Hôpitaux de Paris - Hôpital Necker - Service de Radiologie adultes

Paris, 75743 Paris cedex 15, France

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Olivier ROUVIERE, Professor

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Olivier ROUVIERE, Professor

CONTACT

(0)4 72 11 09 51olivier.rouviere@chu-lyon.fr

Fanny CROS

CONTACT

(0)4 72 11 04 00fanny.cros@chu-lyon.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2014

First Posted

November 20, 2014

Study Start

June 9, 2015

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

August 31, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(3)