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

Not Applicable

Completed

• Conditions: terus myomatosus; Urological and Genital Diseases

• Registration Number: ISRCTN14634593
• Lead Sponsor: Isala

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-04-20
• Study Start: 2021-01-12
• Last Update Posted: 22 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 70

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 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 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:<br> 1. ADC value, acquired with MR-DWI<br> 2. Quantitative T2 value, acquired with T2 mapping<br> 3. Ktrans, acquired with DCE imaging<br><br> 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<br>

Secondary Outcome Measures

Name	Time	Method
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