Myoma Screening Study: use of MRI to predict the outcome of ultrasound treatment for benign tumours of the uterus

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN14634593

Enrollment

Registered

2021-01-12

Start date

2015-06-15

Completion date

Unknown

Last updated

2022-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterus myomatosus Urological and Genital Diseases

Interventions

1. Magnetic Resonance Image-guided High-Intensity Focused Ultrasound (MR-HIFU) 2. Multi-parametric MRI sequences Patients included in this study will undergo three ext

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria: 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 10 cm 6. Distance skin – uterine fibroid >12 cm

Design outcomes

Primary

Measure	Time frame
An MRI scan including possible predictive values for a successful MR-HIFU treatment on symptomatic uterine fibroids will be performed before MR-HIFU treatment, directly after MR-HIFU treatment and at 6 months follow-up. The MRI protocol includes the following parameters: 1. ADC value, acquired with MR-DWI 2. Quantitative T2 value, acquired with T2 mapping 3. Ktrans, acquired with DCE imaging 4. Successful treatment defined as a symptom reduction of minimal 10 points on the UFS-QoL questionnaire before MR-HIFU treatment and at 3, 6 and 12 months follow-up	—

Measure

Time frame

An MRI scan including possible predictive values for a successful MR-HIFU treatment on symptomatic uterine fibroids will be performed before MR-HIFU treatment, directly after MR-HIFU treatment and at 6 months follow-up. The MRI protocol includes the following parameters: 1. ADC value, acquired with MR-DWI 2. Quantitative T2 value, acquired with T2 mapping 3. Ktrans, acquired with DCE imaging 4. Successful treatment defined as a symptom reduction of minimal 10 points on the UFS-QoL questionnaire before MR-HIFU treatment and at 3, 6 and 12 months follow-up

—

Secondary

Measure	Time frame
The feasibility of measuring thermal ablation effects from MR-HIFU in the treatment of uterine fibroids, using ADC mapping and T2 mapping MRI sequences at baseline, on treatment day and at 6 months follow-up	—

Countries

Netherlands

Contacts

Public ContactKimberley Anneveldt

k.j.anneveldt@isala.nl+31 (0)38 424 5000

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 20, 2026