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
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)