Targeted vessel ablation of type 3 uterine fibroids with magnetic resonance guided high intensity focused ultrasound
- Conditions
- uterine fibroiduterine myoma100385951002990310013326
- Registration Number
- NL-OMON43988
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
- Women, aged at least 18 years;
- Able to give informed consent;
- A type 3 uterine fibroid;
- Sufficient physical condition to undergo deep sedation;
- Waist circumference that allows positioning on the HIFU table top inside the MR bore.
- Contra-indication for MRI scanning according to the hospital guidelines;
- Contra-indication to injection of gadolinium-based contrast agent, including known prior allergic reaction to any contrast agent, and renal failure (GFR < 30 mL/min/1.73 m2);
- Surgical clips or considerable scar tissue in the HIFU beam path;
- A total of more than ten fibroids;
- Post- or peri-menopausal status;
- Fibroid size >10 cm in diameter;
- Patient has an active pelvic infection;
- Patient has an undiagnosed pelvic mass outside the uterus;
- Patient who is not able to tolerate the required stationary prone position during treatment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main endpoint of this feasibility study is the manipulation of perfusion in<br /><br>the type 3 uterine fibroid. This will be assessed by comparing the results of<br /><br>dynamic contrast-enhanced MRI (DCE-MRI) before and after treatment and after<br /><br>three months (± 2 weeks), i.e. the time to peak values and the regional blood<br /><br>volumes (area under the curve) and of a so-called time-spatial labeling<br /><br>inversion pulse (TimeSLIP) MR sequence that visualizes the blood vessels<br /><br>without usage of a contrast agent before and directly after ablating the<br /><br>feeding vessels (hence, before ablation the remaining fibroid volume).<br /><br>Furthermore adverse effects will be documented up to three months (± 2 weeks)<br /><br>post HIFU. </p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary objective is to assess if the Funaki classification for fibroids<br /><br>is based on differences in perfusion. The relationship between perfusion and<br /><br>the Funaki classification will be investigated using the area under the curve<br /><br>of the dynamic contrast-enhanced series obtained during the clinically obtained<br /><br>screening MR scan.<br /><br><br /><br>The tertiary objective is to investigate the effect of the targeted vessel<br /><br>ablation technique on the non-perfused volume (NPV) obtained from contrast<br /><br>enhanced MR images directly post treatment. Therefore, we will compare the<br /><br>results from this study against the results of previously treated patients.<br /><br>Furthermore, the obtained NPVs will be compared to those reported in literature<br /><br>for type 3 fibroids.</p><br>