Evaluation of Different Methods of Ultrasound Image Analysis for Real-time Monitoring of HIFU Prostate Cancer Treatment Feasibility Study

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The ELASTO-US study is a single center feasibility study to evaluate 3 methods of analyzing real-time ultrasound images acquired during High Intensity Focused Ultrasound (HIFU) treatment in patients with localized prostate cancer. Real-time ultrasound acquisitions will be programmed at specific times and recorded during HIFU treatment. At the end of the treatment, these recordings will be exported in an anonymized way and analyzed according to the 3 different methods. A multiparametric-MRI will be performed in addition to the usual practice within 5 days after the treatment in order to control the area necroticised by the treatment. The mp-MRI will be the reference method against which the results obtained by the 3 methods of ultrasound image analysis will be compared. Techniques capable of providing safe and robust information on the progress of HIFU-generated necrosis would greatly limit the risks of overtreatment that can lead to side effects such as urinary incontinence as well as the risks of under treatment that can lead to cancer recurrence.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 50
Healthy Volunteers: f
View:

• Patient who has been clearly informed of the study and has agreed, with sufficient time for reflection, to participate by signing the study informed consent form.

• Male aged ≥ 50 years,

• PSA ≤ 15 ng/mL

• diagnosis of localized prostate cancer (stage T1 or T2) with a Gleason score of ≤ 7

• Focal, hemiablation or ablation HIFU treatment validated in Multidisciplinary Concerted Meeting

• Patient enrolled in Medicare or equivalent plan.

• Interpretable preoperative multiparametric MRI performed within 180 days prior to surgery

Locations
Other Locations
France
Service d'Urologie et Chirurgie de la Transplantation - Hôpital Edouard Herriot - Hospices Civils de Lyon
RECRUITING
Lyon
Contact Information
Primary
Sébastien Crouzet, Pr
Sebastien.crouzet@chu-lyon.fr
04 72 11 03 25
Backup
Marjolaine Beaudoin, Msc
Marjolaine.beaudoin@chu-lyon.fr
0472117494
Time Frame
Start Date: 2023-03-09
Estimated Completion Date: 2025-04-14
Participants
Target number of participants: 40
Treatments
Experimental: Patients with localized prostate cancer
Patients with localized prostate cancer for which focal treatment, hemi-ablation or total ablation of the prostate is indicated will be treated by HIFU applied by FocalOne device.
Sponsors
Collaborators: EDAP TMS S.A.
Leads: Hospices Civils de Lyon

This content was sourced from clinicaltrials.gov

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