The FIRSTT: Comparing MRgFUS(MR-guided Focused Ultrasound) Versus UAE (Uterine Artery Embolization)for Uterine Fibroids.

Sponsor

Mayo Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT00995878

Collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)

Enrollment

Locations

Arms

91.1

Actual Duration (Months)

18.7

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary goal of this study is to compare the safety and effectiveness of two standard fibroid treatments: MRI guided ultrasound surgery (MRgFUS) and uterine artery embolization (UAE). Both treatments are approved by the Food and Drug Administration (FDA) for women who do not plan to become pregnant.

A second goal of this study is to better understand which symptoms bother women with fibroids the most. Understanding and addressing the symptoms of clinically-significant uterine fibroids is important in order to optimize treatment outcomes and control health care costs.

Women who are eligible to participate in the study, are randomized to one of two treatment arms (UAE or MRgFUS). Women in both arms will receive treatment but will not be able to choose which treatment she will receive.

A comprehensive assessment of symptoms-including experienced pain- will take place at baseline, 6 weeks, and at 6, 12, 24, and 36 months following treatment with UAE and MRgFUS.

Condition or Disease	Intervention/Treatment	Phase
Symptomatic Uterine Leiomyomas Fibroids Uterine Fibroids Myomas	Procedure: Focused ultrasound (MRgFUS) Procedure: Uterine artery embolization (UAE)	Phase 4

Detailed Description

Uterine fibroids affect up to 70 to 80% of women and about 30% of women are symptomatic. Over 200,000 hysterectomies are performed each year for uterine fibroids in the USA. The direct health care costs attributable to uterine fibroids exceed $2.1 billion annually. Fibroids are reported to cause a number of symptoms including heavy or prolonged menstrual bleeding, pelvic pressure, pain with menses and bowel and bladder dysfunction. However, fibroid symptomatology is incompletely understood. Understanding and addressing the myomas pain are important in optimizing treatment outcomes and controlling health care costs from a societal perspective. This study proposes to optimally characterize symptoms and symptom relief in women with leiomyomas severe enough to seek interventional therapy. Secondly we will characterize a variety of symptoms utilizing standardized instruments for other pelvic diseases and symptoms to optimize comparisons with other disease processes.

Clinical and scientific significance of the studies is high. We look to generate resources which can be used at a later time to assess the biologic and genetic variables affecting treatment outcome and to comprehensively assess the societal economic impact of uterine fibroids and their treatment with UAE and MRgFUS.

Participants will be in the study for up to 36 months following fibroid treatment.

Study Design

Study Type:

Interventional

Actual Enrollment :

56 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The FIRSTT Study: Comparing Focused Ultrasound and Uterine Artery Embolization for Uterine Fibroids

Actual Study Start Date :

Apr 29, 2010

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Focused Ultrasound (MRgFUS)	Procedure: Focused ultrasound (MRgFUS) MRgFUS treatment will take place in a MRI machine and powerful ultrasound waves go through the abdominal wall to destroy the fibroid or fibroids. No incision is made during this treatment and light sedation is required. There are certain fibroids that may not be treated with this technique and there is no treatment of normal uterine tissue.ough the abdominal wall to destroy the fibroid. Other Names: ExAblate 2000
Active Comparator: Uterine Artery Embolization (UAE)	Procedure: Uterine artery embolization (UAE) UAE treatment takes place on a regular x-ray machine. A small incision is made where the leg meets the trunk and a small tube is used to use very small pellets to block off the blood supply to the entire uterus. Sedation is used. Most fibroids are treated with this technique and normal uterine tissue is also affected. Other Names: Uterine Fibroid Embolization UFE

Arm

Intervention/Treatment

Active Comparator: Focused Ultrasound (MRgFUS)

Procedure: Focused ultrasound (MRgFUS)

MRgFUS treatment will take place in a MRI machine and powerful ultrasound waves go through the abdominal wall to destroy the fibroid or fibroids. No incision is made during this treatment and light sedation is required. There are certain fibroids that may not be treated with this technique and there is no treatment of normal uterine tissue.ough the abdominal wall to destroy the fibroid.

Other Names:

ExAblate 2000

Active Comparator: Uterine Artery Embolization (UAE)

Procedure: Uterine artery embolization (UAE)

UAE treatment takes place on a regular x-ray machine. A small incision is made where the leg meets the trunk and a small tube is used to use very small pellets to block off the blood supply to the entire uterus. Sedation is used. Most fibroids are treated with this technique and normal uterine tissue is also affected.

Other Names:

Uterine Fibroid Embolization

UFE

Outcome Measures

Primary Outcome Measures

Symptomatic outcomes measured by validated instruments [At baseline, 6 weeks and 6, 12, 24, and 36 months following treatment.]

Secondary Outcome Measures

Adverse events following treatment [At baseline, 6 weeks and 6, 12, 24 and 36 months following treatment.]
Biologic predictors of outcome [Blood sample is obtained at baseline and at 12, 24, and 36 months following treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Women able to give informed consent and willing and able to attend all study visits
Premenopausal women at least 25 years of age
No evidence of High Grade SIL by pap smears or HPV testing within institutional guidelines.

Exclusion Criteria:

Women actively trying for pregnancy or currently pregnant
Uterine size > 20 weeks
Prior myomectomy, UAE, or MRgFUS. Previous hysteroscopic or laparoscopic myomectomy for the removal of only pedunculated leiomyomas (as described in #17, below) will be allowed and evaluated on an individual basis to determine eligibility for treatment.
More than 6 fibroids > than 3 centimeters in maximal diameter
Allergy to either gadolinium or iodinated contrast
Implanted metallic device prohibiting MRI
Severe claustrophobia
BMI which prohibits subject from fitting in MRI device
Severe abdominal scarring precluding safe MRgFUS treatment
Active pelvic infection
Intrauterine contraceptive device in place at the time of treatment
Current use of GnRH agonists or antagonists
Unstable medical conditions requiring additional monitoring during the procedure
Bleeding diathesis requiring medical treatment
Imaging suggestive of malignant disease of uterus, ovary, or cervix
Imaging suggestive of only adenomyosis
Pedunculated submucosal or subserosal myoma with a stalk less than 25% of the maximal fibroid diameter

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, San Francisco	San Francisco	California	United States	94116
2	Mayo Clinic	Rochester	Minnesota	United States	55905
3	Duke University Health System	Durham	North Carolina	United States	27705