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

NCT02879851 | Unknown

• 1 other identifier: 69HCL16_0422
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer of the Prostate

Keywords

ultrasound; Koelis system; MRI; gold grain

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Influence on TRE3D of the position of the fiducials (apex, midgland and base)

  1 month

• Influence on TRE3D of the experience of the fusion operators

  1 month

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hospital of Edouard Herriot

Lyon, 69003, France

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Olivier ROUVIERE, Professor

CONTACT

+334 72 11 09 50; olivier.rouviere@chu-lyon.fr

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2016
• First Posted: August 26, 2016
• Study Start: January 1, 2015
• Primary Completion: December 1, 2017
• Last Updated: August 26, 2016

Record last verified: 2016-08

Locations

FR (1)