Clinical trial · Interventional
Targeted Vessel Ablation of Type 3 Uterine Fibroids With Magnetic Resonance Guided High Intensity Focused Ultrasound
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
So-called type 1 and 2 uterine fibroids are well treatable with Magnetic Resonance guided High Intensity Focused Ultrasound (MR-HIFU). The other type, type 3 fibroids, however, are known for their high perfusion and poor treatment outcome after MR-HIFU. This study proposes a new strategy to treat type 3 fibroids with MR-HIFU. Very precise, small, high-power sonications (heating points) will be used to occlude (part of) the feeding vessels of the fibroid. This deminishes the negative effect of the high perfusion and is hypothesized to transform a type 3 fibroid into a type 2 or possibly even a type 1 fibroid. Consequently, the bulk volume of the fibroid can be treated using the standard approach.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Fibroid | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Magnetic Resonance guided High Intensity Focused Ultrasound | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single arm
- description
- Treatment group Magentic Resonance guided High Intensity Focused Ultrasound will be employed on uterine fibroids
- interventionNames
- Device: Magnetic Resonance guided High Intensity Focused Ultrasound
Primary outcomes (2)
- measure
- Time to peak
- timeFrame
- three months
- description
- The main endpoint of this feasibility study is the manipulation of perfusion in the type 3 uterine fibroid. The perfusion will be assessed by comparing the results of dynamic contrast-enhanced MRI (DCE-MRI) before and after treatment and after three months, i.e. the time to peak values. Data will be analyzed using Philips IntelliSpace Portal.
- measure
- Regional Blood volume
- timeFrame
- Three months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * 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: * 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.
References
Publications (0)
Data not yet available