Evaluation of Different Methods of Ultrasound Image Analysis for Real-time Monitoring of HIFU Prostate Cancer Treatment
ELASTO-US
2 other identifiers
interventional
40
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 27, 2023
CompletedFirst Posted
Study publicly available on registry
February 6, 2023
CompletedStudy Start
First participant enrolled
March 9, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 14, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 14, 2025
CompletedSeptember 4, 2024
September 1, 2024
2.1 years
January 27, 2023
September 2, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The percentage of analyses that could be completed for each of the three HIFU necrosis detection techniques
To determine the feasibility of implementing the Gray Level Histogram, The Nakagami imaging and proposed in this study, different factors will take into account : the quality of the acquired ultrasound images, the quality of the ultrasound image registration and the quality of the MRI image registration. The implementation of passive elastography, one of the three new methods proposed in this study, requires the presence of a sufficient wavefield in the tissue under study. An ultrasound expert will evaluate this aspect and determine whether or not the mechanical properties of the tissue can be assessed by passive elastography.
At day 0
Secondary Outcomes (6)
To determinate the threshold to differenciate the necrotic area from the non necrotic area
at the latest on day 5 after HIFU treatment
To determinate the threshold to differenciate the partially necrotic area from the non necrotic area
at the latest on day 5 after HIFU treatment
To compare the segmentation of the necrotic zone obtained with the studied parameter to the segmentation obtained with the post treatment MRI
at the latest on day 5 after HIFU treatment
To compare the segmentation of the partially necrotic zone obtained with the studied parameter to the segmentation obtained with the post treatment MRI.
at the latest on day 5 after HIFU treatment
To assess of the impact of patient characteristics and treatment history for prostate cancer.
at the latest on day 5 after HIFU treatment
- +1 more secondary outcomes
Study Arms (1)
Patients with localized prostate cancer
EXPERIMENTALPatients 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.
Interventions
HIFU treatment using Focal One (EDAP TMS) combined with the acquisition of additional ultrasound images before, between, and after HIFU shots will be performed.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- an ASA score \>3
- brachytherapy for prostate cancer
- Person of full age protected by law (person under guardianship or curatorship).
- Contraindication to HIFU treatment as defined in the Focal One instructions for use : - Multiple intraprostatic calcifications inducing, on ultrasound, a shadow cone in the prostate preventing the penetration of ultrasound and therefore the realization of the treatment.
- Presence of permanent radioactive implants in the rectal wall.
- Presence of an implant (stent, catheter) located less than 1 cm from the treatment area.
- Fistula of the urinary tract or rectum.
- Anal or rectal fibrosis, anal or rectal stenosis or other abnormalities making insertion of the Focal One® catheter difficult.
- Anatomical abnormality of the rectum or rectal mucosa.
- Patient with an artificial sphincter, penile prosthesis or intraprostatic implant, such as a stent.
- History of inflammatory bowel disease.
- Current urogenital infection (infection should be treated prior to HIFU treatment).
- Patient allergic to latex with known severe reactionsCounter-indications to anesthesia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospices Civils de Lyonlead
- EDAP TMS S.A.collaborator
Study Sites (1)
Service d'Urologie et Chirurgie de la Transplantation - Hôpital Edouard Herriot - Hospices Civils de Lyon
Lyon, 69003, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sébastien Crouzet, Pr
Service d'Urologie et Chirurgie de la Transplantation - Hôpital Edouard Herriot - Hospices Civils de Lyon
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 27, 2023
First Posted
February 6, 2023
Study Start
March 9, 2023
Primary Completion
April 14, 2025
Study Completion
April 14, 2025
Last Updated
September 4, 2024
Record last verified: 2024-09