DESCRIPTION
Magnetic resonance imaging (MRI)-guided high intensity ultrasound ablation is proposed as a noninvasive therapy for uterine fibroids. This technology is also being investigated for the treatment of other benign and malignant tumors.
Uterine leiomyomas (fibroids or myomas) are noncancerous tumors that develop within the muscular walls of the uterus. They are one of the most common conditions affecting women in reproductive years. Symptoms associated with uterine fibroids are prolonged or heavy menstrual bleeding (menorrhagia), pelvic pressure or pain, and rarely, reproductive dysfunction.
Magnetic resonance imaging (MRI) guided high intensity ultrasound ablation is being investigated as a treatment for uterine fibroids. This is a noninvasive procedure that focuses several ultrasonic beams on targeted tissue causing tissue necrosis by thermal coagulation. MRI guides the procedure and monitors the elevation of temperature in the treatment area. This is done in an effort to ensure that only enough energy is used to successfully destroy the fibroid, and not the surrounding tissue.
An example of a device used for this technology is the ExAblate 2000® System (InSightec, Inc.). The U. S. Food and Drug Administration (FDA) has approved this device only for uterine fibroids.
POLICY
MRI-guided high intensity ultrasound ablation for the treatment of uterine fibroids is considered investigational.
MRI-guided high intensity ultrasound ablation for the treatment of other conditions/diseases, including, but not limited to the following: Benign breast neoplasms, lipoma, hepatic hemangioma, liver cancer, breast cancer, malignant bone tumors, sarcoma of the soft tissue, kidney cancer, malignancies in the abdomen and pelvic cavity, carcinoma of the bladder, cancer of the pancreas, lung cancer, and other non-malignant and malignant tumors is considered investigational.
See also:
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ADDITIONAL INFORMATION
There is a lack of published, randomized controlled studies in peer-reviewed literature to support the use of this technology.
SOURCES
Agency for Healthcare Research and Quality. (2007, July) Evidence Report/Technology Assessment Number 154. Management of uterine fibroids: An update of the evidence. Retrieved July 8, 2010 from http://www.ahrq.gov/downloads/pub/evidence/pdf/uterupdate/uterup.pdf.
BlueCross BlueShield Association. Medical Policy Reference Manual. (2:2010). MRI-guided high-intensity ultrasound ablation of uterine fibroids and other tumors (7.01.109). Retrieved July 8, 2010 from BlueWeb. (23 articles and/or guidelines reviewed)
Fennessy, F. M., Tuncali, K., Morrison, P. R., & Tempany, C. M. (2008). Radiologic Clinics of North America, 46 (1), 149-166. (Level 5 Evidence)
Hayes. Medical Technology Directory (2009, May). High-intensity focused ultrasound treatment for prostate cancer. Retrieved March 8, 2011 from www.Hayesinc.com/subscribers.
National Guideline Clearinghouse. American College of Obstetricians and Gynecologists (ACOG). (2008, August). Alternatives to hysterectomy in the management of leiomyomas. Retrieved July 8, 2010 from http://www.guideline.gov/summary/summary.aspx?ss=15&doc_id=13318&string=Alternatives+AND+hysterectomy+AND+management+AND+leimyomas.
National Guideline Clearinghouse. American College of Radiology. (2009). Expert Panel on Interventional Radiology. ACR Appropriateness Criteria® treatment of uterine leiomyomas. Retrieved March 10, 2011 from http://www.guideline.gov/popups/printView.aspx?id=23820.
National Institute for Health and Clinical Excellence. (2007, September). Magnetic resonance imaged-guided transcutaneous focused ultrasound ablation for uterine fibroids. Retrieved July 8, 2010 from http://www.nice.org/uk/nicemedia/pdf/ip/IPG019guidance.pdf.
Pilatou, M., Stewart, E., Meier, S., Fennessy, F., Hynynen, K., Tempany, C., et al. (2009). MRI-based thermal dosimetry and diffusion-weighted imaging of MRI-guided focused ultrasound thermal ablation of uterine fibroids. Journal of Magnetic Resonance Imaging, 20 2), 404-411. (Level 4 Evidence)
Shen, S., Fennessy, F., McDannold, N., Jolesz, F., & Tempany, C. (2009). Image-guided thermal therapy of uterine fibroids. Seminars in Ultrasound, CT and MR, 390 (2) 91-104. (Level 5 Evidence)
U. S. Food and Drug Administration. (2004, October). Center for Devices and Radiological Health. 510(k) Premarket Approval for ExAblate 2000® System – PO40003. Retrieved July 8, 2010 from http://www.accessdata.fda.gov2000®/cdrh_docs/pdf4/P040003a.pdf.
U. S. Food and Drug Administration. (2004, October). Center for Devices and Radiological Health. InSightec, Ltd. Fact sheet. ExAblate 2000®. Retrieved July 8, 2010 from http://222.accessdata.fda.gov/cdrh_docs/pdf4/P040003d.pdf.
ORIGINAL EFFECTIVE DATE: 3/1/2005
MOST RECENT REVIEW DATE: 4/14/2011
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