Information for professionalsRM_Admin2020-10-20T13:43:29+00:00
The MYCHOICE study was conceived and set up by the MR-HIFU team of Isala Zwolle. This team consists of radiologist and principal investigator dr. M.F. Boomsma, gynecologist dr. J.M. Schutte, gynecologist drs. J.R. Dijkstra, senior scientist dr. I.M. Nijholt and physician-researcher drs. K.J. Anneveldt. Outside Isala, there is support from local investigators: Dr. W.J. Hehenkamp (Amsterdam UMC), Prof. S. Veersema (UMC Utrecht), Dr. P. Lohle (ETZ). Gynecologist Prof. Dr. A. Franx, HTA expert Dr. G.W.J. Frederix, implementation expert Dr. E. Ista, the patient organizations Ikone and Bekkenbodem4all and the professional societies NVOG and NVvR support the team.
Summary of study protocol
Rationale: Roughly 1.8 million Dutch women have uterine fibroids, with 25% reporting complaints. Symptomatic fibroids have a significant impact on Quality of Life (QoL). Conservative treatment fails in 50% of patients, resulting in an indication for an invasive procedure. A hysterectomy is the most common invasive treatment, but has a high risk of complications and long recovery times. Myomectomy is uterus saving, but comes with long recovery and high risk of complications as well. This leads to a strong desire for less invasive treatment options, especially in women who want to conceive. Currently, uterine artery embolization (UAE) is the only reimbursed minimally invasive treatment option in the Netherlands. Magnetic Resonance image guided High Intensity Focused Ultrasound (MR-HIFU) is a rather new non-invasive treatment option. It is safe, (cost)effective and has a very short recovery time and fewer complications compared to surgical intervention and UAE. However, a lack of comparative information on long-term (cost)effectiveness of the MR-HIFU treatment compared to the standard of care, keeps the MR-HIFU treatment from being reimbursed.
Objective: To determine the long-term (cost)effectiveness of Magnetic Resonance image guided High Intensity Focused Ultrasound (MR-HIFU) compared to standard (minimally) invasive fibroid care including UAE, myomectomy and hysterectomy.
Study design: The MYCHOICE study is a national, multicenter, open randomized controlled trial with randomization in a 2:1 ratio to MR-HIFU or standard care including hysterectomy, myomectomy and UAE. The non-inferiority margin is set to 15 points SSS reduction of the UFS-QoL (range: 0-100). With an estimated drop-out of 20%, the sample size is 240 patients in 2:1 ratio for MR-HIFU (n=160) and standard care (n=80). Both an intention-to-treat and per protocol analysis will be performed. Follow-up will be 24 months.
Study population: In brief: Women ≥18 years, premenopausal, diagnosed with symptomatic uterine fibroids in whom conservative treatment failed or is undesired, eligible for MR-HIFU.
Exclusion criteria: MRI contra-indications, suspicion of malignancy, dominant adenomyosis, BMI ≥35kg/m2, currently pregnant or active wish to conceive and not able or willing to sign informed consent.
Intervention: The studied intervention MR-HIFU, leads to significant symptom reduction, less complications, the possibility to conceive and faster recovery than current standards of care.
Main study endpoints: Primary outcomes of the study are the QoL at 24 months after treatment (measured by the UFS-QoL symptom severity score (SSS)) and the costs consisting of direct health care costs, loss of productivity and patient costs. Secondary outcomes include time-interval between treatment and re-intervention, adverse events (AE’s)/complications, patient reported outcome measures (PROM’s), patient reported experience measures (PREM’s), pregnancy outcomes, onset of menopause, length of hospital stay, peri- and post procedural pain, (co)medication use and non-perfused volume/fibroid shrinkage.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: By collecting data on the long-term (cost)effectiveness of the MR-HIFU treatment in comparison to the current standard of fibroid care, we provide currently unavailable evidence about the proper place of MR-HIFU in the fibroid treatment spectrum. We expect our study to lead to reimbursement and implementation of the intervention in national uterine fibroid care guidelines, making the treatment available for all uterine fibroid patients. Based on the current evidence, we believe that the risk for the patient undergoing the intervention is very small, especially when compared to the expected individual gains: uterus preservation and short(er) recovery times leading to less productivity loss. In terms of burden, all patients need to fill in a questionnaire before and four times after treatment.
Referral of patients
Patients who wish to participate in the MYCHOICE study must be referred to one of the participating centers. There they will be counseled at the gynecology outpatient department for the MYCHOICE study and additionally with a member of the research team. If the patient turns out to be eligible for the MR-HIFU treatment after a screening MRI-scan, they will be randomized to either the MR-HIFU treatment, or the non MR-HIFU group. In the latter case, they may choose between embolization, myomectomy or hysterectomy. These treatments will take place in the hospital to which they have been referred. If your patient participates in the MYCHOICE study, you will be notified.
MR-HIFU treatment of symptomatic uterine myomatosus
MR-HIFU (Magnetic Resonance guided High-Intensity Focused Ultrasound) is an innovative and synergistic combination of two techniques: imaging and treatment. Using ultrasound energy, tissue can be ablated in a minimally invasive way to case necrosis (“operate without cutting”). Simultaneously, MRI imaging is used for real-time planning, control and monitoring of the result. Moreover, MRI is used in advance for the selection of patients. Currently, the most widely used application of MR-HIFU is the treatment of uterine fibroids.
Since June 2016, the treatment of fibroids using MR-HIFU has been successfully carried out in Isala Zwolle within the framework of scientific research. The University Medical Center Utrecht and Isala Zwolle are currently the only hospitals in the Benelux that offer this treatment for fibroids.
A systematic literature review and the experiences of Isala Zwolle both indicate that this new treatment method offers many advantages over common practice. The MR-HIFU treatment of fibroids is (cost-)effective, non-invasive, uterine saving, can be performed in day treatment and is associated with a short recovery time and few complications. However, the percentage of long-term re-interventions has not yet been properly investigated.
During the MR-HIFU treatment, a special transducer focuses the ultrasound energy at a certain point in the fibroid (the focal point). At this point, the tissue is locally heated above 55°C, causing protein denaturation and eventually necrosis. Several short sonications are delivered with continuous thermal feedback to measure temperature changes in the fibroid but also to check for uncontrolled heating of front and back tissues such as the “far field” including the sacral plexus or the so-called “near field” including the abdominal wall. The transducer is part of the MRI table, on which the patient lies on her abdomen during treatment. In addition to monitoring temperature changes, real-time MRI is used to determine the exact location of the treatment and to visualize the uterus and surrounding tissues.
The treated tissue of the fibroid will be (partly) absorbed by the body, causing the fibroid to shrink in the months after the treatment. It is therefore expected that the symptoms related to the fibroid will decrease. All organs and tissues around the uterus, such as the bladder, nerves and intestines will be spared. At the end of the treatment, an MRI scan with contrast will be performed so the result of the treatment can be visualized. The treatment can be performed in day treatment.
Not all women are eligible for the MR-HIFU treatment. A screening MRI-scan must show whether the fibroid can be reached sufficiently, to see there are no structures (ovaries, intestines) between the beam and the fibroid, the subcutaneous fat is not too thick and the signal intensity on the MRI scan is not too high. In addition, women must be 18 years of age or older and pre- or peri menopausal.
In the past, a pregnancy wish was a contraindication for MR HIFU treatment. However, many spontaneous pregnancies after MR HIFU have been reported. As a result, the FDA has now approved MR-HIFU treatment in women with a pregnancy wish. To date, however, there have been no randomized trials comparing pregnancy outcomes after MR HIFU treatment with other minimally invasive treatments or myomectomy. Patients who have a future pregnancy wish may participate in the MYCHOICE study if this does not involve an active pregnancy wish (<1 year).
For more information about the MR-HIFU treatment, you can contact us via the contact form.
Looking for a new collaboration?
In case you are interested in collaborating with the MYCHOICE research team, please contact us via the contact form or via email@example.com.