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

Cancer of the Prostate Clinical Trial

— EFEL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02879851
• Other study ID #: 69HCL16_0422
• Status: Recruiting
• Phase: N/A
• First received: August 9, 2016
• Last updated: August 22, 2016
• Start date: January 2015

Study information

• Verified date: August 2016
• Source: Hospices Civils de Lyon
• Contact: Olivier ROUVIERE, Professor
• Phone: +334 72 11 09 50
• Email: olivier.rouviere[@]chu-lyon.fr
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Cancer of the Prostate
• Prostatic Neoplasms

Locations

Country	Name	City	State
France	Hospital of Edouard Herriot	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of the overall registration obtained by the Koelis™ system	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	No
Secondary	Influence on TRE3D of the position of the fiducials (apex, midgland and base)	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	No
Secondary	Influence on TRE3D of the experience of the fusion operators	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	No