uterine fibroid uterine myoma
Conditions
Interventions
During the MR-HIFU treatment, the local vascular feeding network will be
selectively targeted first with high power sonications with the intention to
reduce or interrupt the perfusion of the entire
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - 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.
Exclusion criteria
Exclusion criteria: - 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main endpoint of this feasibility study is the manipulation of perfusion in the type 3 uterine fibroid. This will be assessed by comparing the results of dynamic contrast-enhanced MRI (DCE-MRI) before and after treatment and after three months (± 2 weeks), i.e. the time to peak values and the regional blood volumes (area under the curve) and of a so-called time-spatial labeling inversion pulse (TimeSLIP) MR sequence that visualizes the blood vessels without usage of a contrast agent before and directly after ablating the feeding vessels (hence, before ablation the remaining fibroid volume). Furthermore adverse effects will be documented up to three months (± 2 weeks) post HIFU. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective is to assess if the Funaki classification for fibroids is based on differences in perfusion. The relationship between perfusion and the Funaki classification will be investigated using the area under the curve of the dynamic contrast-enhanced series obtained during the clinically obtained screening MR scan. The tertiary objective is to investigate the effect of the targeted vessel ablation technique on the non-perfused volume (NPV) obtained from contrast enhanced MR images directly post treatment. Therefore, we will compare the results from this study against the results of previously treated patients. Furthermore, the obtained NPVs will be compared to those reported in literature for type 3 fibroids. | — |
Countries
Netherlands
Outcome results
None listed