Condition category
Urological and Genital Diseases
Date applied
05/01/2021
Date assigned
12/01/2021
Last edited
12/01/2021
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results

Plain English Summary

Background and study aims
Uterine fibroids are noncancerous growths of the uterus that often appear during childbearing years. MR-HIFU uses non-invasive high-intensity focused ultrasound (HIFU) guided by magnetic resonance (MR) to treat uterine fibroids. Research is still in progress on the optimal criteria for patient selection for the treatment of uterine fibroids with MR-HIFU. The results of MR-HIFU treatment show a large variety in volume and symptom reduction. Knowledge of MRI-based predictors of success before treatment may improve patient selection, treatment planning and treatment outcomes. Secondly, directly after treatment contrast-enhanced MRI is needed to see the treatment results. Because HIFU sonications are not allowed after the use of a contrast agent, treatment results can only be seen after the total treatment. Therefore, MRI parameters (without the use of a contrast agent) are also studied for visualizing treatment results. The aim of this study is twofold. The first aim is to study the MRI parameters for predicting treatment outcomes before treatment. The second aim is to find an MRI parameter capable of visualizing and measuring the treated tissue as a replacement for contrast-enhanced imaging in order to eliminate the use of a contrast agent.

Who can participate?
Women, aged between 18 and 59, diagnosed with uterine fibroids and related symptoms and willing to undergo MR-HIFU treatment

What does the study involve?
An MRI scan with three additional MRI sequences will be performed to decide eligibility. If eligible and willing to undergo MR-HIFU treatment, a symptom-specific and quality of life questionnaire needs to be filled in. A comparable MRI scan will be performed 6 months after MR-HIFU treatment and the same questionnaire needs to be filled in at 3, 6 and 12 months after treatment.

What are the possible benefits and risks of participating?
Patients included in this study will undergo three extra MRI sequences during MRI examination. The additional MRI sequences have no additional risks compared to standard MRI. No additional contrast agent is used compared to standard MR-HIFU. By participating, patients have the opportunity to undergo the non-reimbursed MR-HIFU treatment and contribute to improving this non-invasive treatment option.

Where is the study run from?
Isala Hospital (Netherlands)

When is the study starting and how long is it expected to run for?
January 2015 to April 2020

Who is funding the study?
Isala Hospital (Netherlands)

Who is the main contact?
Dr M.F. Boomsma
m.f.boomsma@isala.nl

Trial website

Contact information

Type

Scientific

Primary contact

Dr Martijn Boomsma

ORCID ID

http://orcid.org/0000-0002-7878-0970

Contact details

Dokter ven Heesweg 2
Zwolle
8025 AB
Netherlands
+31 (0)38 424 5000
m.f.boomsma@isala.nl

Type

Public

Additional contact

Ms Kimberley Anneveldt

ORCID ID

http://orcid.org/0000-0002-4546-1148

Contact details

Dokter ven Heesweg 2
Zwolle
8025 AB
Netherlands
+31 (0)38 424 5000
k.j.anneveldt@isala.nl

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

MaSSII: NL56182.075.16, MaSS: NL53499.075.15

Study information

Scientific title

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

Acronym

MaSSII and MaSS

Study hypothesis

Multiparametric MRI can be used as a predictive value for a successful MR-HIFU treatment of uterine fibroids. MRI parameters include ADC value (acquired with MR-DWI), quantitative T2-value (acquired with T2-mapping) and K-trans (acquired with DCE imaging). A successful treatment is determined as a symptom reduction of minimal 10 points on the UFS-QoL questionnaire.

Ethics approval

MaSSII (NL56182.075.16): Approved 01/11/2016, Isala Zwolle The Netherlands Medical Ethical Review Board (METC Isala
Gebouw Mondriaan, kamer 0.47, Postbus 10400, 8000 GK Zwolle, The Netherlands; +31 (0)38 4243082; METC@isala.nl), ref: 16.0479.
MaSS (NL53499.075.15): Approved 15/06/2015, Isala Zwolle The Netherlands Medical Ethical Review Board (METC Isala
Gebouw Mondriaan, kamer 0.47, Postbus 10400, 8000 GK Zwolle, The Netherlands; +31 (0)38 4243082; METC@isala.nl), ref: 15.0580

Study design

Prospective single-center non-randomized interventional study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Uterus myomatosus

Intervention

1. Magnetic Resonance Image-guided High-Intensity Focused Ultrasound (MR-HIFU)
2. Multi-parametric MRI sequences

Patients included in this study will undergo three extra MRI sequences during MRI examination. The MRI sequences are acquired in a supine position, just as the conventional sequences during MR-HIFU treatment. Also, the patients are asked to complete the UFS-QoL questionnaire four times: before MR-HIFU treatment and at 3, 6 and 12 months follow-up.

Intervention type

Device

Phase

Not Applicable

Drug names

Primary outcome measure

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 outcome measures

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

Overall trial start date

01/01/2015

Overall trial end date

20/04/2020

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

50

Total final enrolment

70

Participant 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

Recruitment start date

15/06/2015

Recruitment end date

01/02/2019

Locations

Countries of recruitment

Netherlands

Trial participating centre

Isala Hospital
Dokter ven Heesweg 2
Zwolle
8025 AB
Netherlands

Sponsor information

Organisation

Isala

Sponsor details

Dokter ven Heesweg 2
Zwolle
8025 AB
Netherlands
+31 (0)38 424 5000
m.f.boomsma@isala.nl

Sponsor type

Hospital/treatment centre

Website

http://www.isala.nl/

Funders

Funder type

Hospital/treatment centre

Funder name

Isala Hospital

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

1. The study protocols are not published yet and will not become available either in the future. Protocol data will indirectly be provided by registration in this registry and by the methods section in the publications.
2. Publications in high-impact peer-reviewed journals.

IPD sharing statement
The datasets generated during and/or analysed during the current study are not expected to be made available. Since no approval was requested from the participants to share data, only group-level data on specific outcomes or timepoints can be requested. Complete data registers, statistical analyses etc. cannot be provided.

Intention to publish date

10/03/2020

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

2020 MaSS results in https://pubmed.ncbi.nlm.nih.gov/32219676/ (added 05/01/2021)
2020 MaSSII results in https://pubmed.ncbi.nlm.nih.gov/32166489/ (added 05/01/2021)

Publication citations

Additional files

Editorial Notes

05/01/2021: Trial's existence confirmed by Isala Zwolle The Netherlands Medical Ethical Review Board.