Clinical trial NCT03948789: Phase III Study of MR-Guided Focused Ultrasound Surgery for the Treatment of Uterine Fibroids Compared to Myomectomy
Official title: Multicenter, Randomized Phase III Study of MR-Guided Focused Ultrasound Surgery for the Treatment of Uterine Fibroids (MRgFUS TUF) Compared to Myomectomy in Symptomatic Medication and Not Sufficiently Treatable Uterine Fibroids
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Uterine Fibroids
Lead sponsor: Krankenhaus Nordwest
Sponsor class: OTHER
First posted: 2019-05-14
Enrollment: 127
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: WAI question 4
timeFrame: Until at least three consecutive days questionnaire was answered as indicated, up to 12 months
measure: Symptom Severity Score of the UFS-QoL
timeFrame: 12 months after treatment
Secondary outcomes:
measure: Hospital stay in days
timeFrame: 12 months after treatment
measure: Pain according to visual analog scale
timeFrame: 12 months after treatment
measure: Number of Adverse Events (AEs)
timeFrame: 12 months after treatment
measure: Number of postinterventional/postsurgery treatment complications
timeFrame: 12 months after treatment
measure: Number of re-interventions
timeFrame: 12 months after treatment
measure: Alleviation of symptoms (irregular period, unfulfilled wish for child, pain, quality of life according to UFS-QoL
timeFrame: 12 months after treatment
measure: Health related quality of life according to UFS-QoL
timeFrame: 12 months after treatment
measure: Sexuality related parameters according to UFS-QoL
timeFrame: 12 months after treatment
measure: Number of pregnancies and live births
timeFrame: 12 months after treatment
measure: Number of late complications like venous thromboembolisms within Follow up time frame
timeFrame: 12 months after treatment
measure: Number of fibroid recurrences (de novo fibroids) within Follow up time frame
timeFrame: 12 months after treatment
measure: Time period until return to normal physical activities, measured by the rate of patients, who achieved an a priori clinically relevant reduction of SSS of UFS-QoL
timeFrame: 12 months after treatment
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Krankenhaus Nordwest
state: Hessen
city: Göttingen
country: Germany
facility: FOKUS Radiologische Gemeinschaftspraxis
city: Leipzig
country: Germany
facility: Leipzig University
city: Stuttgart
country: Germany
facility: Marienhospital
Study officials:
affiliation: Krankenhaus Nordwest
name: Thorsten O Götze, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: