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

Uterine Fibroids Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00995878
• Other study ID #: 09-005095
• Secondary ID: 1RC1HD063312-01
• Status: Completed
• Phase: Phase 4
• First received: October 13, 2009
• Last updated: January 10, 2018
• Start date: April 29, 2010
• Est. completion date: December 2017

Study information

• Verified date: January 2018
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years and older

Eligibility

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.

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

Related Conditions & MeSH terms

• Fibroids
• Leiomyoma
• Myomas
• Symptomatic Uterine Leiomyomas
• Uterine Fibroids

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Duke University Health System	Durham	North Carolina
United States	Mayo Clinic	Rochester	Minnesota
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptomatic outcomes measured by validated instruments		At baseline, 6 weeks and 6, 12, 24, and 36 months following treatment.
Secondary	Adverse events following treatment		At baseline, 6 weeks and 6, 12, 24 and 36 months following treatment.
Secondary	Biologic predictors of outcome		Blood sample is obtained at baseline and at 12, 24, and 36 months following treatment

External Links

•   Focused Ultrasound Foundation on MRgFUS
•   Mayo Clinic Uterine Fibroid Facebook page sharing educational information related to fibroids.
•   Mayo Clinic Uterine Fibroids Information
•   National Institute of Child Health and Human Development
•   Radiology Society of North America Information on UFE