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

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ClinicalTrials.gov Identifier: NCT03948789
Recruitment Status : Recruiting
First Posted : May 14, 2019
Last Update Posted : September 11, 2020
Sponsor:
Information provided by (Responsible Party):
Krankenhaus Nordwest

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.

Condition or disease Intervention/treatment Phase
Uterine Fibroids Procedure: Magnetic Resonance Imaging-controlled high-focussed ultrasound therapy Procedure: Myomectomy (laparoscopic or open surgical) Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 127 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 15, 2020
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: A Myomectomy
Removement of uterine fibroids by myomectomy
Procedure: Myomectomy (laparoscopic or open surgical)
Myomectomy (laparoscopic or open surgical)

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




Primary Outcome Measures :
  1. WAI question 4 [ Time Frame: Until at least three consecutive days questionnaire was answered as indicated, up to 12 months ]
    Time to sustainably return to normal activities, based on the daily Work Activity Index (WAI) dimension, "Estimated Impairment of Disease Performance". The return to normal activities is considered to be given if the question "Hindrance of medical condition or injury at work?" (min max: 1: 'in my opinion, I am completely unable to work', 6: 'No Disability') is answered for at least three consecutive days with "No Disability" (6) or "I can do my job, but have complaints" (5).

  2. Symptom Severity Score of the UFS-QoL [ Time Frame: 12 months after treatment ]
    The symptom severity is determined to be the co- primary endpoint for assessing therapeutic efficacy, based on the SSS (Symptom Severity Score) of the UFS-QoL (Uterine fibroid symptom and quality of life questionnaire). The co-primary assessment is performed 12 months after the primary treatment and for the evaluation the proportion of patients with at least 25 points improvement in the SSS is determined (0-100 scale, 100 indicating very strong symptoms, 0 no or low symptoms).


Secondary Outcome Measures :
  1. Hospital stay in days [ Time Frame: 12 months after treatment ]
  2. Pain according to visual analog scale [ Time Frame: 12 months after treatment ]
    Visual analog scale ranges from 0-100, 0 indicating no pain, 100 severe pain

  3. Number of Adverse Events (AEs) [ Time Frame: 12 months after treatment ]
  4. Number of postinterventional/postsurgery treatment complications [ Time Frame: 12 months after treatment ]
  5. Number of re-interventions [ Time Frame: 12 months after treatment ]
  6. Alleviation of symptoms (irregular period, unfulfilled wish for child, pain, quality of life according to UFS-QoL [ Time Frame: 12 months after treatment ]
    QoL: Quality of Life score regarding symptoms, ranges from 0-100, 0 indicating very low QoL, 100 indicating very high QoL

  7. Health related quality of life according to UFS-QoL [ Time Frame: 12 months after treatment ]
    QoL: Quality of Life score regarding health, ranges from 0-100, 0 indicating very low QoL, 100 indicating very high QoL

  8. Sexuality related parameters according to UFS-QoL [ Time Frame: 12 months after treatment ]
    QoL: Quality of Life score regarding sexuality, ranges from 0-100, 0 indicating very low QoL, 100 indicating very high QoL

  9. Number of pregnancies and live births [ Time Frame: 12 months after treatment ]
  10. Number of late complications like venous thromboembolisms within Follow up time frame [ Time Frame: 12 months after treatment ]
  11. Number of fibroid recurrences (de novo fibroids) within Follow up time frame [ Time Frame: 12 months after treatment ]
  12. 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 [ Time Frame: 12 months after treatment ]
    at timepoints: months 1, 3 and 6 compared to baseline.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03948789


Contacts
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Contact: Thorsten O Götze, PD Dr. med. 06976014187 goetze.thorsten@khnw.de

Locations
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Germany
Krankenhaus Nordwest Recruiting
Frankfurt, Hessen, Germany, 60488
Contact: Markus Düx, Prof. Dr.         
FOKUS Radiologische Gemeinschaftspraxis Recruiting
Göttingen, Germany
Contact: Peter Hunold, PD Dr.         
Leipzig University Recruiting
Leipzig, Germany
Contact: Bahriye Aktas, Prof. Dr.         
Contact: Nikolaos Bailis         
Marienhospital Recruiting
Stuttgart, Germany
Contact: Markus Zähringer, Prof. Dr.         
Contact: Manfred Hofmann, PD Dr.         
Sponsors and Collaborators
Krankenhaus Nordwest
Investigators
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Principal Investigator: Thorsten O Götze, PD Dr. med. Krankenhaus Nordwest
Additional Information:
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Responsible Party: Krankenhaus Nordwest
ClinicalTrials.gov Identifier: NCT03948789    
Other Study ID Numbers: MARGI-T
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: September 11, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases