Back to resultsPhase III Study of MR-Guided Focused Ultrasound Surgery for the Treatment of Uterine Fibroids Compared to Myomectomy
Primary Purpose
Uterine Fibroids
Status
Recruiting
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Magnetic Resonance Imaging-controlled high-focussed ultrasound therapy
Myomectomy (laparoscopic or open surgical)
Sponsored by
About this trial
This is an interventional treatment trial for Uterine Fibroids
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
Sites / Locations
- Krankenhaus NordwestRecruiting
- FOKUS Radiologische GemeinschaftspraxisRecruiting
- Leipzig UniversityRecruiting
- MarienhospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
A Myomectomy
B MRgFUS-TUF
Arm Description
Removement of uterine fibroids by myomectomy
Removement of uterine fibroids by Magnetic Resonance Imaging-controlled high-focussed ultrasound therapy (MRgFUS-TUF)
Outcomes
Primary Outcome Measures
WAI question 4
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).
Symptom Severity Score of the UFS-QoL
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
Hospital stay in days
Pain according to visual analog scale
Visual analog scale ranges from 0-100, 0 indicating no pain, 100 severe pain
Number of Adverse Events (AEs)
Number of postinterventional/postsurgery treatment complications
Number of re-interventions
Alleviation of symptoms (irregular period, unfulfilled wish for child, pain, quality of life according to UFS-QoL
QoL: Quality of Life score regarding symptoms, ranges from 0-100, 0 indicating very low QoL, 100 indicating very high QoL
Health related quality of life according to UFS-QoL
QoL: Quality of Life score regarding health, ranges from 0-100, 0 indicating very low QoL, 100 indicating very high QoL
Sexuality related parameters according to UFS-QoL
QoL: Quality of Life score regarding sexuality, ranges from 0-100, 0 indicating very low QoL, 100 indicating very high QoL
Number of pregnancies and live births
Number of late complications like venous thromboembolisms within Follow up time frame
Number of fibroid recurrences (de novo fibroids) within Follow up time frame
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
at timepoints: months 1, 3 and 6 compared to baseline.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03948789
Brief Title
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
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2020 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
March 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Krankenhaus Nordwest
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Fibroids
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
127 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A Myomectomy
Arm Type
Active Comparator
Arm Description
Removement of uterine fibroids by myomectomy
Arm Title
B MRgFUS-TUF
Arm Type
Experimental
Arm Description
Removement of uterine fibroids by Magnetic Resonance Imaging-controlled high-focussed ultrasound therapy (MRgFUS-TUF)
Intervention Type
Procedure
Intervention Name(s)
Magnetic Resonance Imaging-controlled high-focussed ultrasound therapy
Intervention Description
Magnetic Resonance Imaging-controlled high-focussed ultrasound
Intervention Type
Procedure
Intervention Name(s)
Myomectomy (laparoscopic or open surgical)
Intervention Description
Myomectomy (laparoscopic or open surgical)
Primary Outcome Measure Information:
Title
WAI question 4
Description
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).
Time Frame
Until at least three consecutive days questionnaire was answered as indicated, up to 12 months
Title
Symptom Severity Score of the UFS-QoL
Description
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).
Time Frame
12 months after treatment
Secondary Outcome Measure Information:
Title
Hospital stay in days
Time Frame
12 months after treatment
Title
Pain according to visual analog scale
Description
Visual analog scale ranges from 0-100, 0 indicating no pain, 100 severe pain
Time Frame
12 months after treatment
Title
Number of Adverse Events (AEs)
Time Frame
12 months after treatment
Title
Number of postinterventional/postsurgery treatment complications
Time Frame
12 months after treatment
Title
Number of re-interventions
Time Frame
12 months after treatment
Title
Alleviation of symptoms (irregular period, unfulfilled wish for child, pain, quality of life according to UFS-QoL
Description
QoL: Quality of Life score regarding symptoms, ranges from 0-100, 0 indicating very low QoL, 100 indicating very high QoL
Time Frame
12 months after treatment
Title
Health related quality of life according to UFS-QoL
Description
QoL: Quality of Life score regarding health, ranges from 0-100, 0 indicating very low QoL, 100 indicating very high QoL
Time Frame
12 months after treatment
Title
Sexuality related parameters according to UFS-QoL
Description
QoL: Quality of Life score regarding sexuality, ranges from 0-100, 0 indicating very low QoL, 100 indicating very high QoL
Time Frame
12 months after treatment
Title
Number of pregnancies and live births
Time Frame
12 months after treatment
Title
Number of late complications like venous thromboembolisms within Follow up time frame
Time Frame
12 months after treatment
Title
Number of fibroid recurrences (de novo fibroids) within Follow up time frame
Time Frame
12 months after treatment
Title
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
Description
at timepoints: months 1, 3 and 6 compared to baseline.
Time Frame
12 months after treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thorsten O Götze, PD Dr. med.
Phone
06976014187
Email
goetze.thorsten@khnw.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thorsten O Götze, PD Dr. med.
Organizational Affiliation
Krankenhaus Nordwest
Official's Role
Principal Investigator
Facility Information:
Facility Name
Krankenhaus Nordwest
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60488
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Markus Düx, Prof. Dr.
Facility Name
FOKUS Radiologische Gemeinschaftspraxis
City
Göttingen
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Hunold, PD Dr.
Facility Name
Leipzig University
City
Leipzig
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bahriye Aktas, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Nikolaos Bailis
Facility Name
Marienhospital
City
Stuttgart
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Markus Zähringer, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Manfred Hofmann, PD Dr.
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.aerzteblatt.de/nachrichten/98991/Erster-G-BA-Auftrag-zu...1%20von%202%2027.11.2018%2014:10
Description
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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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