Myoma Screening Study: use of MRI to predict the outcome of ultrasound treatment for benign tumours of the uterus
| ISRCTN | ISRCTN14634593 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14634593 |
| Secondary identifying numbers | MaSSII: NL56182.075.16, MaSS: NL53499.075.15 |
- Submission date
- 05/01/2021
- Registration date
- 12/01/2021
- Last edited
- 10/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
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
Contact information
Scientific
Dokter ven Heesweg 2
Zwolle
8025 AB
Netherlands
 ORCID ID |
0000-0002-7878-0970 |
|---|---|
| Phone | +31 (0)38 424 5000 |
| m.f.boomsma@isala.nl |
Public
Dokter ven Heesweg 2
Zwolle
8025 AB
Netherlands
| ORCID ID |
0000-0002-4546-1148 |
|---|---|
| Phone | +31 (0)38 424 5000 |
| k.j.anneveldt@isala.nl |
Study information
| Study design | Prospective single-center non-randomized interventional study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| 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 |
| Study acronym | MaSSII and MaSS |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| 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 study start date | 01/01/2015 |
| Completion date | 20/04/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 50 |
| Total final enrolment | 70 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 15/06/2015 |
| Date of final enrolment | 01/02/2019 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Zwolle
8025 AB
Netherlands
Sponsor information
Hospital/treatment centre
Dokter ven Heesweg 2
Zwolle
8025 AB
Netherlands
| Phone | +31 (0)38 424 5000 |
|---|---|
| m.f.boomsma@isala.nl | |
| Website | http://www.isala.nl/ |
"ROR" |
https://ror.org/046a2wj10 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 10/03/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| 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 plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | MaSS results | 01/10/2020 | 05/01/2021 | Yes | No |
| Results article | MaSSII results | 01/07/2020 | 05/01/2021 | Yes | No |
| Other publications | Lessons learned during implementation | 18/12/2021 | 20/12/2021 | Yes | No |
| Results article | 18/12/2021 | 10/08/2022 | Yes | No |
Editorial Notes
10/08/2022: Publication reference added.
20/12/2021: Publication reference added.
05/01/2021: Trial's existence confirmed by Isala Zwolle The Netherlands Medical Ethical Review Board.
