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

Phase 4

Completed

• Conditions: Symptomatic Uterine Leiomyomas; Myomas; Uterine Fibroids; Fibroids
• Interventions: Procedure: Uterine artery embolization (UAE); Procedure: Focused ultrasound (MRgFUS)

• Registration Number: NCT00995878
• Lead Sponsor: Mayo Clinic

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.

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 Timeline

• Study First Submitted: 2009-10-13
• Study First Submitted QC: 2009-10-14
• Study First Posted: 2009-10-15
• Study Start: 2010-04-29
• Primary Completion: 2016-12
• Study Completion: 2017-12
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-10
• Last Update Posted: 2018-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 56

Inclusion Criteria

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

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Exclusion Criteria

1. Women actively trying for pregnancy or currently pregnant
2. Uterine size > 20 weeks
3. 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.
4. More than 6 fibroids > than 3 centimeters in maximal diameter
5. Allergy to either gadolinium or iodinated contrast
6. Implanted metallic device prohibiting MRI
7. Severe claustrophobia
8. BMI which prohibits subject from fitting in MRI device
9. Severe abdominal scarring precluding safe MRgFUS treatment
10. Active pelvic infection
11. Intrauterine contraceptive device in place at the time of treatment
12. Current use of GnRH agonists or antagonists
13. Unstable medical conditions requiring additional monitoring during the procedure
14. Bleeding diathesis requiring medical treatment
15. Imaging suggestive of malignant disease of uterus, ovary, or cervix
16. Imaging suggestive of only adenomyosis
17. Pedunculated submucosal or subserosal myoma with a stalk less than 25% of the maximal fibroid diameter

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Uterine Artery Embolization (UAE)	Uterine artery embolization (UAE)	-
Focused Ultrasound (MRgFUS)	Focused ultrasound (MRgFUS)	-

Primary Outcome Measures

Name	Time	Method
Symptomatic outcomes measured by validated instruments	At baseline, 6 weeks and 6, 12, 24, and 36 months following treatment.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

Duke University Health System; 🇺🇸 Durham, North Carolina, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States