Protocol Number: 09-CH-0063

Title:

Pilot Study of MRI-Guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids

Number:

09-CH-0063

Summary:

Uterine fibroids (leiomyomas) are a common cause of heavy uterine bleeding and pain in reproductive aged women and are the most common cause of hysterectomy in the United States. Women are seeking new ways to treat symptomatic uterine fibroids that allow them to avoid surgery. This study is the first step in this quest. We will study the novel use of magnetic resonance imaging (MRI) in enhancing the safety of the FDA approved technique to treat fibroids called High Intensity Focused Ultrasound (HIFU). The term high intensity focused ultrasound' means using ultrasound to heat and to thermally destroy tissue, in this case, uterine fibroids. The MRI system will allow us to watch the ultrasound path during treatment and monitor the temperature increase in the fibroid tissue that comes during the procedure.

In this pilot study, women with symptomatic fibroids will undergo MRI guided HIFU and then have a hysterectomy. This will allow us to confirm studies done in animals which show that it is possible to destroy specific tissue without harming normal tissue surrounding the targeted area.

The purpose of this clinical study is to confirm the safety and treatment capabilities of the Philips MR guided HIFU system for ablation of uterine fibroids. This is a single arm pilot study of 10 women who will undergo hysterectomy after the HIFU procedure. This study design of hysterectomy after treatment has been requested by the FDA as part of IDE approval for this new device and mirrors what has been required for similar devices. Safety will be assessed by evaluating treatment accuracy, complications, and adverse events. Treatment capabilities will be assessed by evaluating the fibroid volume ablated and other factors related to the procedure feasibility and acceptance including procedure duration, time to return to normal activity, and pain scores at the time of the procedure.

Study population

The Philips MR-HIFU System is intended for ablation of uterine fibroid tissue in pre- or perimenopausal women with symptomatic uterine fibroids who desire a uterine-sparing procedure. Patients must have completed child bearing prior to enrolling in this study. Patients will be recruited by referral to gynecology and interventional radiology at the NIH Clinical Center. Candidates for enrollment will already have symptomatic uterine leiomyomas and be willing to undergo hysterectomy for treatment. It is estimated that of apparently eligible subjects, at least 30 women will have to be screened in person in order to identify 10 who will be eligible for this study. Other studies of fibroid treatments are currently ongoing at the NIH. Women who have been interested in, but have not been selected for enrollment in those studies and who appear to be eligible to this study will be contacted for potential enrollment.

Study design:

This study is a multi-center, single arm trial evaluating the safety and treatment capabilities of the Philips MR-guided HIFU system in the treatment of symptomatic uterine fibroid patients who are otherwise healthy women. All patients enrolled in the study will undergo hysterectomy within a window of 30 days following HIFU treatment. Patients who have symptomatic uterine fibroids, meet clinical indications for hysterectomy, are eligible according to the inclusion and exclusion criteria and provide informed consent will be enrolled in this study. This study design of treatment followed by hysterectomy has been requested by the FDA as part of IDE approval for this new device and mirrors what has been required for similar devices. It is anticipated that women will participate in the study for a 3 month period to include the screening, HIFU treatment, hysterectomy and post hysterectomy follow-up.

The methodology used for this HIFU device capitalizes on the thermal properties of volumetric ablation rather than point ablation used by other focused ultrasound systems. Thus it is anticipated that this device will have a shorter treatment time compared to other HIFU machines. This HIFU system, via real-time MR thermometry monitoring, has automated thermal feedback during the procedure which may enhance safety. This pilot study will not only assess the safety of this device but will enable us to delineate the treatment capabilities of this system for future use in patients who want uterine sparing non-surgical treatment for symptomatic fibroids.

Primary Outcome paramet...

Sponsoring Institute:

National Institute of Child Health and Human Development (NICHD)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Female

Referral Letter Required: No

Population Exclusion(s): Male

Children

Eligibility Criteria:

INCLUSION CRITERIA:

1. Female gender

2. Age between 30 and 59

3. Pre or peri menopausal with FSH less than 40 mIU/ml

4. Weight less than 140kg (or 310lbs)

5. Cervical cytology no more severe than low grade SIL

6. Negative urine pregnancy test

7. Uterine size less than 24 weeks based on MRI and physical exam assessment

8. Symptom severity score greater than or equal to 50 by Spies Uterine Fibroid Questionnaire.

9. History of uterine leiomyoma causing symptoms of bleeding, pressure, or pain, as defined by the ACOG practice bulletin (ACOG Practice Bulletin 1994):

Excessive uterine bleeding will be evidenced by either of the following: profuse bleeding with flooding or clots or repetitive periods lasting for more than 8 days; or anemia due to acute or chronic blood loss

OR

Pelvic discomfort caused by leiomyomata, either acute and severe or chronic lower abdominal or low back pressure or bladder pressure with urinary frequency not due to urinary tract infection

10. Largest fibroid greater than or equal to 3 cm and less than or equal to 16 cm on imaging.

11. Excellent health other than history of leiomyomas. Chronic medications may be acceptable at the discretion of the research team.

12. Completed childbearing.

13. Are using abstinence, mechanical (condoms, diaphragms) or sterilization methods of contraception and are willing to continue using them throughout the study.

14. Willing and able to give informed consent.

15. Willing and able to comply with study requirements.

16. Hemoglobin greater than 10 g/dL (for those wishing surgery); iron may be administered to improve red blood cell counts.

17. GFR greater than 60 ml/min/1.73sq.m

[As calculated using the Modified Diet in Renal Disease (MDRD) equation of Levey et. al.]

18. Liver function tests within 130% of upper limit

19. Platelet count greater than 50 K/microL

20. Fibroids to be treated with HIFU must be at least 1 cm in diameter

EXCLUSION CRITERIA:

1. Significant abnormalities in the history, physical or laboratory examination

2. History of or current thromboembolic event (deep vein thrombosis, pulmonary embolus, stroke)

3. Other pelvic mass indicated by history or MR imaging such as endometriosis, ovarian tumor, acute or chronic pelvic inflammatory disease

4. Desire for future pregnancy

5. Pregnant or positive pregnancy test

6. Lactation

7. Unexplained vaginal bleeding

8. Untreated severe cervical dysplasia

9. Abnormal adnexal/ovarian mass

10. Intrauterine device

11. Need for interval use of narcotics

12. Contraindication to anesthesia

13. Hematocrit less than 30%

14. Extensive scarring along anterior lower abdominal wall (greater than 50% of area) or scar tissue or surgical clips in the direct path of the HIFU beam

15. MRI or MRI contrast agent contraindicated

16. Unable to quantify or measure fibroids on MR exam, including nonenhancing fibroids

17. Claustrophobia preventing ability to tolerate MRI

18. Fibroid or uterine calcifications

19. Fibroid that must be excluded from treatment:

a. Fibroids less than 1 cm

b. Pedunculated fibroids with a stalk less than 30% of the total fibroid volume

c. Submucosal fibroids greater than 5 cm

20. Genetic causes of leiomyomata

21. Known recent rapid growth of fibroids, defined as a doubling in size in 6 months

Special Instructions:

Currently Not Provided

Keywords:

High Intensity Focused Ultrasound Ablation

Uterine Fibroids

Leiomyomata

Non-Invasive Treatment of Uterine Fibroids

MRI-Guided

Recruitment Keyword(s):

Fibroids

Uterine Fibroids

Uterine Leiomyomata

Condition(s):

Uterine Fibroids

Uterine Leiomyomata

Investigational Drug(s):

None

Investigational Device(s):

HIFU Device

Intervention(s):

Device: HIFU Device

Supporting Site:

National Institute of Child Health and Human Development

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Fennessy FM, Tempany CM, McDannold NJ, So MJ, Hesley G, Gostout B, Kim HS, Holland GA, Sarti DA, Hynynen K, Jolesz FA, Stewart EA. Uterine leiomyomas: MR imaging-guided focused ultrasound surgery--results of different treatment protocols. Radiology. 2007 Jun;243(3):885-93. Epub 2007 Apr 19.

Flynn M, Jamison M, Datta S, Myers E. Health care resource use for uterine fibroid tumors in the United States. Am J Obstet Gynecol. 2006 Oct;195(4):955-64. Epub 2006 May 24.

Hindley J, Gedroyc WM, Regan L, Stewart E, Tempany C, Hynyen K, Mcdannold N,Inbar Y, Itzchak Y, Rabinovici J, Kim HS, Geschwind JF, Hesley G, Gostout B,Ehrenstein T, Hengst S, Sklair-Levy M, Shushan A, Jolesz F.MRI guidance of focused ultrasound therapy of uterine fibroids: early results. AJR Am J Roentgenol. 2004 Dec;183(6):1713-9.

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