MaSSII: MRI-based prognostic biomarkers for treatment success of minimal invasive treatment for uterine fibroids with magnetic resonance guided high intensity focused ultrasound (MR-HIFU) MaSS: In-depth analysis of biological tissue characteristics of uterine fibroids using new MRI techniques

Isala0 个研究点目标入组 70 人开始时间: 2021年1月12日最近更新: 2022年8月22日

试验速览

2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32219676/ MaSS results (added 05/01/2021) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32166489/ MaSSII results (added 05/01/2021) 2021 Other publications in https://pubmed.ncbi.nlm.nih.gov/34921657/ Lessons learned during implementation (added 20/12/2021) 2021 Results article in https://doi.org/10.1186/s13244-021-01128-w (added 10/08/2022)

•For MRI screening inclusion, the following criteria are applied based on anamnesis, physical examination and vaginal ultrasonography:
•1. 18–59 years old
•2. Uterine fibroid related symptoms
•3. Pre- or perimenopausal
•To determine whether the patient is eligible for the MR-HIFU treatment after the screening MRI, the following inclusion criteria are used:
•1. Type 1 & 2 uterine fibroids (based on Funaki classification)
•2. Diameter of 1-10 cm of dominant fibroid

•Exclusion criteria for the MRI screening, based on anamnesis, physical examination and vaginal ultrasonography, are defined as follows:
•1. Post-menopausal
•2. Wish for future fertility
•3. Pregnancy
•4. Severe abdominal obesity or BMI >40
•5. Uterine artery embolization in medical history
•6. MRI contra-indications
•7. Calcifications in uterine fibroid
•To determine whether the patient is eligible for the MR-HIFU treatment after screening MRI, the following exclusion criteria are used.
•1. Type 3 uterine fibroids (based on Funaki classification)
•2. Calcified or pedunculated uterine fibroids
•3. Close to sciatic nerve or sacrum
•4. Interposition of bowel or ovary
•5. Diameter of <1 cm or >10 cm
•6. Distance skin – uterine fibroid >12 cm

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