Therapeutic Magnetic Resonance Imaging (MRI)-Guided High Intensity Focused Ultrasound (HIFU) Ablation of Uterine Fibroids
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Purpose
This study is to confirm the safety and technical effectiveness of MRI guided High Intensity Focused Ultrasound (HIFU) in ablating uterine tissue associated with symptomatic leiomyomas. The importance of this therapy is that it offers a non-invasive, uterine sparing procedure for the treatment of uterine fibroids in pre- and peri- menopausal women.
MRI guided high intensity focused ultrasound uses ultrasound to heat and thermally ablate fibroid tissue. The MRI system identifies the ultrasound path and monitors heat rise in the fibroid tissue. The goal of the study is to show treatment safety and technical effectiveness. MR-guided HIFU will be performed in patients who pass inclusion/exclusion criteria. Safety, quality of life, and imaging endpoints will be evaluated in all study patients.
The goal of this study is to demonstrate that:
- The safety profile is acceptable (safety)
- Actual MR-HIFU ablated volumes (as measured with contrast enhanced MRI) match the intended volumes (technical effectiveness)
- When intended, volumes greater than 20% of the fibroid volume can be successfully ablated (technical effectiveness)
The investigators' hypothesis is that greater than 70% of fibroids will have concordance between intended lesion volume and actual lesion volume while maintaining an acceptable safety profile.
| Condition | Intervention |
|---|---|
|
Uterine Fibroids |
Device: Philips MRI-guided HIFU system |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Clinical Trial Protocol for Therapeutic MRI-guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids |
- Adverse Events/Subject Resulting From HIFU Treatment of the Uterine Fibroids [ Time Frame: 30 days after treatment ] [ Designated as safety issue: Yes ]The number of Adverse Events reported during the study, divided by the total number of treated subjects. This corresponds to the mean number of Adverse Events per subject.
- Fibroid Symptom Severity Score (SSS) From the Uterine Fibroid Symptoms - Quality of Life (UFS-QoL) Questionnaire. [ Time Frame: At baseline and at 30 days following treatment ] [ Designated as safety issue: No ]
Mean absolute change in the Symptom Severity Score (SSS) of the Uterine Fibroid Symptoms - Quality of Life (UFS-QoL) questionnaire after fibroid treatment with HIFU.
The SSS is a scale from 0-100, where 0 corresponds to no symptoms and 100 corresponds to the most severe symptoms.
| Enrollment: | 33 |
| Study Start Date: | April 2009 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Treated leiomyomas
Pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure receive a treatment with the Philips MRI-guided HIFU system. Patients must have completed child bearing prior to enrolling in this study.
|
Device: Philips MRI-guided HIFU system
HIFU is the use of focused ultrasound energy to penetrate through soft tissue and causes localized high temperatures (55°C to 70°C) for a few seconds within the target producing well defined regions of protein denaturation, irreversible cell damage, and coagulative necrosis.
Other Name: Sonalleve
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 59 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Women, age between 18 and 59 years
- Weight < 140kg
- Pre- or peri-menopausal
- Uterine size < 24 weeks
- Transformed SSS score > 40
- Normal Cervical cell assessment by PAP
- Symptomatic Fibroid disease
- Dominant fibroid greater than or equal to 3cm and less than or equal to 12 cm
Exclusion Criteria:
- Other Pelvic Disease
- Desire for future pregnancy
- Significant systemic disease even if controlled
- Positive pregnancy test
- Hematocrit < 25%
- Scarring or other interference of the HIFU beam
- MRI or contrast contraindicated
- Fibroids not quantifiable on MRI
- Calcifications around or throughout uterine tissues
- Communication barrier
Contacts and Locations| France | |
| Hospital St. Andre | |
| Bordeaux, France | |
| Germany | |
| University Hospital Schleswig-Holstein | |
| Lübeck, Germany | |
| Korea, Republic of | |
| Samsung Medical Center | |
| Seoul, Korea, Republic of | |
| Netherlands | |
| University Medical Center | |
| Utrecht, Netherlands | |
| Principal Investigator: | Herve Trillaud, Prof, MD | Hospital St. Andre, Bordeaux, France |
| Principal Investigator: | Lim Hyo Keun, MD | Samsung Medical Center, Seoul, Korea |
| Principal Investigator: | Willem Mali, Prof, MD | University Medical Center - Utrecht, Netherlands |
| Principal Investigator: | Joerg Barkhausen, Prof, MD | University Hospital Schleswig-Holstein, Lübeck, Germany |
More Information
Publications:
| Responsible Party: | Philips Healthcare |
| ClinicalTrials.gov Identifier: | NCT00897897 History of Changes |
| Other Study ID Numbers: | 996233 |
| Study First Received: | May 11, 2009 |
| Results First Received: | July 5, 2011 |
| Last Updated: | December 3, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Philips Healthcare:
|
Uterine Leiomyomas Fibroids HIFU Ablation High Intensity Focused Ultrasound |
Additional relevant MeSH terms:
|
Leiomyoma Myofibroma Neoplasms, Muscle Tissue Neoplasms, Connective and Soft Tissue |
Neoplasms by Histologic Type Neoplasms Neoplasms, Connective Tissue Connective Tissue Diseases |
ClinicalTrials.gov processed this record on June 18, 2013