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出境医 / 临床实验 / Phase III Study of MR-Guided Focused Ultrasound Surgery for the Treatment of Uterine Fibroids Compared to Myomectomy
Phase III Study of MR-Guided Focused Ultrasound Surgery for the Treatment of Uterine Fibroids Compared to Myomectomy
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.
| 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 |
Study Design
| 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 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: A Myomectomy
Removement of uterine fibroids by myomectomy
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Procedure: Myomectomy (laparoscopic or open surgical)
Myomectomy (laparoscopic or open surgical)
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Experimental: B MRgFUS-TUF
Removement of uterine fibroids by Magnetic Resonance Imaging-controlled high-focussed ultrasound therapy (MRgFUS-TUF)
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Procedure: Magnetic Resonance Imaging-controlled high-focussed ultrasound therapy
Magnetic Resonance Imaging-controlled high-focussed ultrasound
|
Outcome Measures
Primary Outcome Measures :
- 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).
- 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 :
- Hospital stay in days [ Time Frame: 12 months after treatment ]
- 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
- Number of Adverse Events (AEs) [ Time Frame: 12 months after treatment ]
- Number of postinterventional/postsurgery treatment complications [ Time Frame: 12 months after treatment ]
- Number of re-interventions [ Time Frame: 12 months after treatment ]
- 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
- 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
- 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
- Number of pregnancies and live births [ Time Frame: 12 months after treatment ]
- Number of late complications like venous thromboembolisms within Follow up time frame [ Time Frame: 12 months after treatment ]
- Number of fibroid recurrences (de novo fibroids) within Follow up time frame [ Time Frame: 12 months after treatment ]
- 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.
Eligibility Criteria
| 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
Contacts and Locations
Contacts
| Contact: Thorsten O Götze, PD Dr. med. | 06976014187 | goetze.thorsten@khnw.de |
Locations
| 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
| Principal Investigator: | Thorsten O Götze, PD Dr. med. | Krankenhaus Nordwest |
| Tracking Information | |||||||
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| First Submitted Date ICMJE | May 10, 2019 | ||||||
| First Posted Date ICMJE | May 14, 2019 | ||||||
| Last Update Posted Date | September 11, 2020 | ||||||
| Actual Study Start Date ICMJE | July 15, 2020 | ||||||
| Estimated Primary Completion Date | March 2022 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | |||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | Phase III Study of MR-Guided Focused Ultrasound Surgery for the Treatment of Uterine Fibroids Compared to Myomectomy | ||||||
| Official Title ICMJE | 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 | ||||||
| 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. | ||||||
| Detailed Description | Not Provided | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Phase 3 | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE | Uterine Fibroids | ||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Recruiting | ||||||
| Estimated Enrollment ICMJE |
127 | ||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||
| Estimated Study Completion Date ICMJE | December 2022 | ||||||
| Estimated Primary Completion Date | March 2022 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Germany | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT03948789 | ||||||
| Other Study ID Numbers ICMJE | MARGI-T | ||||||
| Has Data Monitoring Committee | Yes | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Krankenhaus Nordwest | ||||||
| Study Sponsor ICMJE | Krankenhaus Nordwest | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
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| PRS Account | Krankenhaus Nordwest | ||||||
| Verification Date | September 2020 | ||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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