Phase III Study of MR-Guided Focused Ultrasound Surgery for the Treatment of Uterine Fibroids Compared to Myomectomy

Krankenhaus Nordwest

Status and phase: Active, not recruiting; Phase 3

Conditions: Uterine Fibroids

Treatments: Procedure: Magnetic Resonance Imaging-controlled high-focussed ultrasound therapy; Procedure: Myomectomy (laparoscopic or open surgical)

Study type: Interventional

Funder types: Other

Identifiers

NCT03948789

MARGI-T

Details and patient eligibility

About

The aim of the study is to answer the question, whether in patients with symptomatic and medically not sufficiently treatable uterine fibroids (population) the "Magnetic-Resonance-Guided Focused Ultrasound Surgery" short, MRgFUS-TUF (intervention) offers less burdensome therapy and patient-relevant advantages (symptom relief) compared to the operative myomectomy (comparison). The study will hence investigate the therapeutic benefit of this method.

Enrollment: 127 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women with symptomatic and medically untreatable uterine fibroids who score at least 40 points on the Symptom Severity Score (SSS) of the Uterine Fibroid Symptom and Quality of Life Questionnaire (UFS- QoL )
• Safe access for the MRgFUS possible (anatomical position of the fibroids): Pelvic magnetic resonance imaging to document the number, location and size of fibroids and to exclude malignancy and other pelvic pathologies; necessary to determine whether MRgFUS can be performed technically (presence of a stable ultrasound window and exclusion of scars in the access path)
• ≤ 5 fibroids requiring treatment
• Fibroids with a diameter ≤ 10 cm
• Total myoma volume ≤ 400 ml
• Patient is suitable for treatment with MRgFUS-TUF as well as for myomectomy
• Desire for least invasive treatment
• Indication for hysteroscopy and fractionated abrasion depending on the bleeding pattern and endometrial thickness and structure have been critically tested in advance.
• inconspicuous cytological smear of the cervix uteri not older than 12 months
• No previous uterine surgery / intervention
• Female patients aged> 18 years. Patients of reproductive age must adhere to appropriate contraception until 6 months after the procedure. (Methods of contraception that meet the criteria of highly effective contraception in the sense of the Note for guidance on non- clinical safety studies for the conduct of human clinical trials for meet pharmaceuticals [CPMP / ICH / 286/95 mod ]). Patients of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment.
• Karnofsky index ≥ 70
• Given medical operability
• Written consent of the patient

Exclusion criteria

• Pretreatment with ulipristal acetate ( Esmya ) ≤ 2 months
• Suspected Malignancy (absolute)
• Pregnancy (absolute)
• acute inflammatory process (absolute)
• Uterus myomatosis with more than 5 fibroids (relative, case-by-case decision)
• Uterine fibroids with a diameter over 10 cm (absolute)
• insufficient sound window can be reached for treatment (eg intestinal overlays, large scars in the acoustic window, very dorsal position of the fibroid)
• subserous stalked fibroids
• Inaccessible location of fibroids
• Scarring in the treatment area
• Recurring abortions
• general contraindications to MR contrast agents
• MRI contraindications
• Presence of pacemaker or metal implants
• Karnofsky Index <70
• Severe hepatic dysfunction (Aspartat-Aminotransferase (AST) / Transaminasen Alanin-Amino-transferase (ALT)> 3.5x ULN (upper limit of normal), Alkalische Phosphatase (AP)> 6xULN)
• Active CHD (congenital heart disease), (symptoms present), cardiomyopathy or heart failure in NYHA (New York Heart Association) and EF (ejection fraction) stage III-IV <45%
• Serious internistic side-diseases or an acute infection
• Chronic inflammatory bowel disease
• Pregnancy or lactation
• Participation in another interventional study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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127 participants in 2 patient groups

A Myomectomy

Active Comparator group

Description:

Removement of uterine fibroids by myomectomy

Treatment:

Procedure: Myomectomy (laparoscopic or open surgical)

B MRgFUS-TUF

Experimental group

Description:

Removement of uterine fibroids by Magnetic Resonance Imaging-controlled high-focussed ultrasound therapy (MRgFUS-TUF)

Treatment:

Procedure: Magnetic Resonance Imaging-controlled high-focussed ultrasound therapy