Trial document



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  DRKS00013526

Trial Description

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Title

Evaluation of suitable criteria for the therapy of uterine fibroids by MR-guided high-intensity focused ultrasound (MR-HIFU)

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Trial Acronym

HIFU-Myom

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URL of the Trial

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Brief Summary in Lay Language


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Brief Summary in Scientific Language

Over the last few decades, minimally invasive, image-guided interventions have gained in importance as an alternative to conventional open surgery or as a supplement to classical radiotherapy or chemotherapy, especially for the local, gentle treatment of tumorous diseases. The special feature of the HIFU compared to the other ablation methods is the completely non-invasive procedure, since the ultrasound source is located extracorporeally.
The Philips Sonalleve System is a CE-certified MR-HIFU system that enables selective tissue heating to 60-80° C under MR image control and MR real-time temperature measurement. Especially for the treatment of uterine fibroids, this approach has already been evaluated as a promising and gentle alternative, which is used in over 150 selected, specialized centers worldwide.
For optimal performance, reliable visualization of the target tissue as well as continuous monitoring of tissue destruction are important. To control the therapy, MRI has proven to be the method of choice due to the combination of excellent soft tissue contrast, multiplanar layering and the absence of ionizing radiation in addition to diagnostic ultrasound. In addition, unlike the US, MRI offers the possibility of true thermometry and diffusion imaging for advanced focal focus imaging.
The MR-HIFU combines the accuracy of MRI imaging with gentle treatment through the use of ultrasound radiation. The method is characterized mainly by the low complication rates and low side effects with overall fast symptomatic improvement. Since 2003, further studies on the use of uterine fibroids have been published. This enabled the MR-HIFU to gain a legitimate status in myoma therapy over time. Compared to current minimally invasive gold standard, the uterine artery embolization (UAE), MR-HIFU achieved a similar result in terms of post-interventional symptom relief.
The aim of the planned MR-HIFU interventions presented here is the evaluation of suitable criteria for the treatment of uterine fibroids by means of MR guided high-intensity focused ultrasound for routine implementation in the Department of Radiology of the Ludwig-Maximilians University Munich. In addition, the pain load as well as the safety and ergonomics should be evaluated within the scope of the application. Furthermore, the cost-effectiveness of the method compared to the UAE and the surgical procedures myomectomy or hysterectomy should be examined.

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Organizational Data

  •   DRKS00013526
  •   2018/05/25
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  •   yes
  •   Approved
  •   18-043, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
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Secondary IDs

  •   internes Register  (LMU-RAD00010)
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Health Condition or Problem studied

  •   D25.0 -  Submucous leiomyoma of uterus
  •   D25.1 -  Intramural leiomyoma of uterus
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Interventions/Observational Groups

  •   The patient is evaluated interdisciplinarily by the treating gynecologist with the request for treatment of a complaint-causing finding (uterine fibroma) and is called for an indication for radiological-interventional therapy.
    A pre-interventional contrast enhanced ultrasound examination is performed and intravenous access is established. In addition, for the duration of the MR-HIFU (high-intensity focused ultrasound) therapy, the installation of a urinary bladder catheter. Subsequently, the patient is positioned on the MRI with built-in HIFU device. Pre-intervention MR images are taken to assess the target region and adjacent structures. Finally, the positioning of the patient takes place. A mild i.v. sedation and analgesation ensures that the patient receives little from the relatively long treatment (about 2-3 h). At 3, 6 and 12 months after successful MR-HIFU therapy a follow-up visit is planned. During that the UFS-QOL quality of life questionnaire will be handed out and a follow-up and MRI scan will be performed.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Achievement of the final follow-up (12 months) or performing any additional myoma therapy (e.g., myomactomy, hysterectomy, or Radiofrequency Ablation (RFA))

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Secondary Outcome

/

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/06/06
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

1. Age of at least 18 years.
2. Current creatinine
3. Indication for local ablative therapy by means of HIFU
4. Accessibility of the fibroid / fibroids with HIFU
5. Funaki Type I-II
6. Signed declaration of consent with compliance incl. Follow-up treatment with compliance including follow-up treatment
7. Size of fibroid <12 cm
8. Exclusion of a leiomyosarcoma
9. Signed declaration of consent

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Exclusion Criteria

1. Taking Ulipristalacetat (Esmya) over the past 6 months
2. General MRI contraindications (pacemakers, metal parts)
3. contrast agent allergy
4. Significantly reduced general condition
5. Massive obesity (BMI> 40)
6. Patients with mental / psychiatric disorders
7. pregnancy
8. intrauterine Device
9. Funaki Type III-IV
10. Pedunculated serous fibroid
11. Detection of a Leiomyosarcoma

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Addresses

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    • Klinikum der Universität München, Campus Großhadern
    • Marchioninistraße 15
    • 81377  München
    • Germany
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    • Klinik und Poliklinik für Radiologie Klinikum der Universität München
    • Mr.  Dr.  Bastian  Sabel 
    • Marchioninistr. 15
    • 81377  München
    • Germany
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    • Klinik und Poliklinik für Radiologie Klinikum der Universität München Campus Großhadern
    • Ms.  Christel  Besseler 
    • Marchioninistr. 15
    • 81377  München
    • Germany
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Sources of Monetary or Material Support

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    • Klinik und Poliklinik für Radiologie Klinikum der Universität München Campus Großhadern
    • Mr.  Prof.  Jens  Ricke 
    • Marchioninistr. 15
    • 81377  München
    • Germany
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    •   (089) 4400-4400 72750
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.