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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A02963-54 | Other Identifier | ANSM |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Myoma elastography | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Myoma elastography | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite criteria | Composite criteria measured from:
| Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| leiomyoma stiffness measured by Resoundant system | leiomyoma stiffness measured by Resoundant system | Baseline |
| leiomyoma stiffness measured by ARFI-US | leiomyoma stiffness measured by ARFI-US |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Bordeaux | Bordeaux | France |
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| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Baseline |
| clinical efficiency | Defined as a decrease of 10pts on UFS-Qol score | month 6 |
| inter-observer reproducibility | inter-observer reproducibility of leiomyoma stiffness measurements by Resoundant system | Baseline |
| leiomyoma perfusion | leiomyoma perfusion (diffusion) | Month 6 |
| leiomyoma T2 signal | It will be evaluated in two ways: The first consists of a qualitative analysis taking as a reference the signal of the paravertebral muscles. Myomas will then be classified into a hypersignal, iso-signal or hyposignal group as compared to muscles (qualitative method according to the classification of Funaki). The second will be a quantitative method. One ROI will be positioned in the myoma and a second in the paravertebral muscle and the ratio of these values will be recorded. | Month 6 |