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 sites70 target enrollmentJanuary 12, 2021

Overview

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)

Registry

who.int

Start Date

January 12, 2021

End Date

April 20, 2020

Last Updated

3 years ago

Study Type

Interventional

Sex

Female

Sponsor

•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)