Evaluation of the Accuracy of the Elastic Fusion MRI-ultrasound Obtained in Vivo by the Koelis™ System (EFEL)

August 22, 2016 updated by: Hospices Civils de Lyon

Evaluation of the Accuracy of the Elastic Fusion MRI-ultrasound ((Magnetic Resonance Imaging) Obtained in Vivo by the Koelis™ System

The study aims at quantifying the registration error obtained in routine patients in different parts of the prostate and for operators with different experience in order to assess the average precision of the elastic MR-ultrasound fusion obtained by Koelis™ system.

Patients referred for placement of intraprostatic fiducials before radiotherapy for prostate cancer will be prospectively offered to enter the study.

The fiducials will be placed under transrectal ultrasound guidance, in the prostate apex, midgland and base, according to our routine procedure. A 3D Ultrasound acquisition of the prostate will be obtained at the end of the placement. As per our routine procedure, patients will undergo unenhanced prostate MRI to control the position of the fiducials. An elastic fusion of the MR images and the 3D ultrasound acquisitions will be retrospectively performed by operators of varying experience using the Koelis system. The fiducials (visible on MR and ultrasound images) will be used to quantify the registration error.

Study Overview

Status

Unknown

Conditions

Cancer of the Prostate

Study Type

Observational

Enrollment (Anticipated)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Lyon, France, 69003
    - Recruiting
    - Hospital of Edouard Herriot
    - Contact:
      
      Olivier ROUVIERE, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Patients with prostate cancer referred for placement of intraprostatic fiducials before prostate radiotherapy

Description

Inclusion Criteria:

Age ≥ 18 years
Patient requiring placement of intraprostatic fiducials
No contra-indication for fiducials placement
No contra -indication to MRI
No contra -indication for intravenous injection of gadolinium chelates
Patient affiliated to the social security system
Patients who received oral and written information

Exclusion Criteria:

Patient deprived of liberty as a result of a judicial or administrative decision.
Patient under guardianship or curatorship.
Any event preventing or prematurely interrupting the collection of assessment criteria would result in the premature exit of the subject.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of the overall registration obtained by the Koelis™ system Time Frame: 1 month	The fusion will be performed retrospectively without interfering with patient management. This fusion is an off-line analysis that will be performed within one month of the images acquisition. Each of the four operators will perform a US/MR fusion for all patients and will be blinded to the fusions performed by the others. The results will be presented when all operators have finished the fusions in all patients. The overall registration error (TRE3D, defined as the Euclidean distance between the US marker and the MR marker after fusion) will be calculated based on the 3D coordinates of the fiducials on MR and ultrasound images.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Influence on TRE3D of the position of the fiducials (apex, midgland and base) Time Frame: 1 month	The fusion will be performed retrospectively without interfering with patient management. This fusion is an off-line analysis that will be performed within one month of the images acquisition. Each of the four operators will perform a US/MR fusion for all patients and will be blinded to the fusions performed by the others. The results will be presented when all operators have finished the fusions in all patients. The distribution of TRE3D for the markers at the apex, midgalnd and base will be compared	1 month
Influence on TRE3D of the experience of the fusion operators Time Frame: 1 month	The fusion will be performed retrospectively without interfering with patient management. This fusion is an off-line analysis that will be performed within one month of the images acquisition. Each of the four operators will perform a US/MR fusion for all patients and will be blinded to the fusions performed by the others. The results will be presented when all operators have finished the fusions in all patients. The distribution of TRE3D for the four operators will be compared	1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (ANTICIPATED)

December 1, 2017

Study Registration Dates

First Submitted

August 9, 2016

First Submitted That Met QC Criteria

August 22, 2016

First Posted (ESTIMATE)

August 26, 2016

Study Record Updates

Last Update Posted (ESTIMATE)