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

Brief Summary

Official Title: “The FIRSTT Study: Comparing Focused Ultrasound and Uterine Artery Embolization for Uterine Fibroids”

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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: December 2014

Detailed Clinical Trial 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.

Interventions Used in this Clinical Trial

  • 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.
  • 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.

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: Focused Ultrasound (MRgFUS)
  • Active Comparator: Uterine Artery Embolization (UAE)

Outcome Measures for this Clinical Trial

Primary Measures

  • Symptomatic outcomes measured by validated instruments
    • Time Frame: At baseline, 6 weeks and 6, 12, 24, and 36 months following treatment.
      Safety Issue?: No

Secondary Measures

  • Adverse events following treatment
    • Time Frame: At baseline, 6 weeks and 6, 12, 24 and 36 months following treatment.
      Safety Issue?: Yes
  • Biologic predictors of outcome
    • Time Frame: Blood sample is obtained at baseline and at 12, 24, and 36 months following treatment
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 25 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Mayo Clinic
  • Collaborator
    • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Elizabeth A. Stewart, Professor of Obstetrics and Gynecology – Mayo Clinic
  • Overall Official(s)
    • Elizabeth A. Stewart, M.D., Principal Investigator, Mayo Clinic

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00995878