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

Study acronym: ELASTO-US
StatusUnknown
PhaseNot applicable
Started

Record status This record was last updated September 4, 2024 (before its estimated April 14, 2025 completion). Its status may not reflect the trial's current state.

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Record History

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  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Recruiting
  2. Primary and study completion dates: Mar 14, 2025 to Apr 14, 2025v6
  3. Primary and study completion dates: Sep 14, 2024 to Mar 14, 2025v5
  4. Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Sep 2024 to Sep 14, 2024
    • Start date changed from estimate of Mar 2023 to Mar 9, 2023
    • Site details revised
    v4
  5. Primary and study completion dates: Aug 2024 to Sep 2024
    • Start date: Feb 2023 to Mar 2023
    v3
  6. Secondary endpoints revised (6)v2
  7. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05714774
Lead Sponsor Hospices Civils de Lyon
Collaborators: EDAP TMS S.A.
Conditions
(from sponsor)		 Prostatic Neoplasms
Related terms Prostatic Neoplasms
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov