Trials / Completed
CompletedNCT04345003
MR Elastography Parameters Impact on MR-HIFU Efficacy in Uterine Fibroids
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- University Hospital, Bordeaux · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Magnetic resonance (MR)-guided high-intensity focused ultrasound (HIFU) ablation for fibroids is an outpatient approach for controlling symptom with an excellent safety record. It is important to exclude in advance patients who would not benefit from this treatment. For that purpose this study assesses the influence of fibroid elasticity and diffusion on ablation efficiency during treatment by MR-HIFU
Detailed description
Pre-procedural predictors of treatment efficacy will be useful for excluding in advance patients who would not get benefit of this treatment. It seems that elastography, cellular density and perfusion could be considered as predictors. Fibroid elastography will be quantified by MRE Resoundant® system and pelvic ultrasound. Perfusion and cellular density will be quantified by MR diffusion.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Myoma elastography | The standard pre-therapeutic assessment includes a pelvic US to eliminate the presence of calcification of fibroids. If this absence is confirmed, the elasticity of uterine myoma (by ARFI method) will be measured. The standard pre-therapeutic MRI performed allows to classify and measure the myoma in order to determine if it is accessible for HIFU treatment. MRI elastography sequence with the Resoundant® system will be performed during this exam. |
Timeline
- Start date
- 2020-06-18
- Primary completion
- 2023-02-21
- Completion
- 2023-08-31
- First posted
- 2020-04-14
- Last updated
- 2023-12-07
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT04345003. Inclusion in this directory is not an endorsement.