Actively Recruiting
Evaluation of Different Methods of Ultrasound Image Analysis for Real-time Monitoring of HIFU Prostate Cancer Treatment
Led by Hospices Civils de Lyon · Updated on 2024-09-04
40
Participants Needed
1
Research Sites
109 weeks
Total Duration
On this page
Sponsors
H
Hospices Civils de Lyon
Lead Sponsor
E
EDAP TMS S.A.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of Different Methods of Ultrasound Image Analysis for Real-time Monitoring of HIFU Prostate Cancer Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male aged �3E= 50 years
- PSA level �3C= 15 ng/mL
- Diagnosed with localized prostate cancer (stage T1 or T2) with a Gleason score �3C= 7
- Focal, hemiablation, or ablation HIFU treatment validated in Multidisciplinary Concerted Meeting
- Enrolled in Medicare or equivalent plan
- Interpretable preoperative multiparametric MRI performed within 180 days before surgery
- Provided informed consent after sufficient reflection
You will not qualify if you...
- ASA score greater than 3
- Previous brachytherapy for prostate cancer
- Person under legal guardianship or curatorship
- Contraindications to HIFU treatment including multiple intraprostatic calcifications causing ultrasound shadowing
- Presence of permanent radioactive implants in the rectal wall
- Presence of an implant (stent, catheter) less than 1 cm from treatment area
- Urinary tract or rectal fistula
- Anal or rectal fibrosis, stenosis, or abnormalities hindering catheter insertion
- Anatomical abnormalities of the rectum or rectal mucosa
- Artificial sphincter, penile prosthesis, or intraprostatic implant such as a stent
- History of inflammatory bowel disease
- Current urogenital infection (must be treated before HIFU)
- Known severe latex allergy
- Contraindications to anesthesia
AI-Screening
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Trial Site Locations
Total: 1 location
1
Service d'Urologie et Chirurgie de la Transplantation - Hôpital Edouard Herriot - Hospices Civils de Lyon
Lyon, France, 69003
Actively Recruiting
Research Team
S
Sébastien Crouzet, Pr
CONTACT
M
Marjolaine Beaudoin, Msc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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