To investigate whether it is possible to manipulate perfusion in type 3 fibroids with MR-HIFU.
ID
Source
Brief title
Condition
- Reproductive neoplasms female benign
- Menstrual cycle and uterine bleeding disorders
- Obstetric and gynaecological therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoint of this feasibility study is the manipulation of perfusion in
the type 3 uterine fibroid. This will be assessed by comparing the results of
dynamic contrast-enhanced MRI (DCE-MRI) before and after treatment and after
three months (± 2 weeks), i.e. the time to peak values and the regional blood
volumes (area under the curve) and of a so-called time-spatial labeling
inversion pulse (TimeSLIP) MR sequence that visualizes the blood vessels
without usage of a contrast agent before and directly after ablating the
feeding vessels (hence, before ablation the remaining fibroid volume).
Furthermore adverse effects will be documented up to three months (± 2 weeks)
post HIFU.
Secondary outcome
The secondary objective is to assess if the Funaki classification for fibroids
is based on differences in perfusion. The relationship between perfusion and
the Funaki classification will be investigated using the area under the curve
of the dynamic contrast-enhanced series obtained during the clinically obtained
screening MR scan.
The tertiary objective is to investigate the effect of the targeted vessel
ablation technique on the non-perfused volume (NPV) obtained from contrast
enhanced MR images directly post treatment. Therefore, we will compare the
results from this study against the results of previously treated patients.
Furthermore, the obtained NPVs will be compared to those reported in literature
for type 3 fibroids.
Background summary
Uterine fibroids or leiomyomas are common benign tumors that arise from smooth
muscle cells of the uterus with a prevalence ranging from 20% to 40% in
reproductive aged women. Invasive treatments, such as hysterectomy and
myomectomy, represent the golden standard with respect to therapy.
Alternatively, uterine artery embolization is offered as a less invasive
option. However, to date the only non-invasive technique is high intensity
focused ultrasound (HIFU) ablation. HIFU ablation uses focused ultrasound waves
to non-invasively heat and thermally ablate tissue. Combined with magnetic
resonance guidance (MR-HIFU) this allows an entirely non-invasive intervention
with anatomical 3D images for the planning of the treatment volume, and
real-time temperature monitoring for therapeutic guidance.
A limitation of MR-HIFU is that currently not all types of uterine fibroids are
treatable. With respect to MR-HIFU treatment, uterine fibroids are classified
in three classes based on the signal intensity of T2-weighted MR images. While
MR-HIFU has been shown to result in a reliable positive therapeutic outcome in
type 1 and type 2 fibroids, the therapeutic success in type 3 fibroids has so
far been limited. The current clinical consensus is that the high perfusion in
type 3 fibroids, which causes the heat deposited by the HIFU to be rapidly
evacuated from the treatment site, results in insufficient temperatures to
induce necrosis in the fibroids. Therefore, a new treatment strategy is
proposed to effectively treat type 3 fibroids with MR-HIFU.
Study objective
To investigate whether it is possible to manipulate perfusion in type 3
fibroids with MR-HIFU.
Study design
Single-center, single arm, non-randomized trial. Ten patients will be treated.
Intervention
During the MR-HIFU treatment, the local vascular feeding network will be
selectively targeted first with high power sonications with the intention to
reduce or interrupt the perfusion of the entire fibroid volume. Subsequently,
the remaining fibroid volume will be ablated, similar to the treatment approach
of type 1/2 fibroids.
Study burden and risks
The fibroid type and the eligibility for MR-HIFU treatment will be determined
on a clinically obtained magnetic resonance imaging (MRI) scan. The result of
the scan and information about this study are provided to the patient during a
phone call. If the patient is interested, the study information is sent by
mail. The patient receives a second phone call to ask if she wishes to
participate. If so, an appointment at the hospital is arranged to give details
on the study, answer questions, and show the clinical MR scan. If the patient
wants to participate, informed consent (IC) is signed. The HIFU treatment will
be scheduled in consultation with the patient.
Patients will be sedated during the HIFU intervention, as it is also the case
during the standard HIFU treatment of type 1/2 fibroids. Compared to the
standard HIFU treatment, the initial selective ablation of the vascular feeding
network with high power sonications will be added. The subsequent therapy for
the remainder of the fibroid will follow the standard therapeutic HIFU
treatment of type 1/2 fibroids.
One week (± 2 days) after the treatment the patient will receive a phone call
to ask about adverse events. Three months (± 2 weeks) after the treatment a
follow-up MR scan, including a DCE scan, will be performed. In addition, the
patient will be asked about any adverse events that might have occurred during
a phone call.
Potential adverse effects include skin burns due to heating of the cutaneous
and sub-cutaneous abdominal fat and risk of abdominal pain due to the occlusion
of the vascular network. To mitigate the risk of skin burns, a cooling cushion
is integrated in the HIFU table top and will protect the skin and part of the
abdominal fat from overheating.
If women with a type 3 fibroid do not want to participate in this study, they
are not eligible for MR-HIFU treatment and are referred by their gynecologist
to a more invasive treatment option like uterine artery embolization or
hysterectomy.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
- Women, aged at least 18 years;
- Able to give informed consent;
- A type 3 uterine fibroid;
- Sufficient physical condition to undergo deep sedation;
- Waist circumference that allows positioning on the HIFU table top inside the MR bore.
Exclusion criteria
- Contra-indication for MRI scanning according to the hospital guidelines;
- Contra-indication to injection of gadolinium-based contrast agent, including known prior allergic reaction to any contrast agent, and renal failure (GFR < 30 mL/min/1.73 m2);
- Surgical clips or considerable scar tissue in the HIFU beam path;
- A total of more than ten fibroids;
- Post- or peri-menopausal status;
- Fibroid size >10 cm in diameter;
- Patient has an active pelvic infection;
- Patient has an undiagnosed pelvic mass outside the uterus;
- Patient who is not able to tolerate the required stationary prone position during treatment.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02633254 |
| CCMO | NL54736.041.15 |