NCT02879851

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2015-01-01
• Primary completion: 2017-12-01
• First posted: 2016-08-26
• Last updated: 2016-08-26

Locations

1 site across 1 country: France