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

January 10, 2018 updated by: Elizabeth A. Stewart, Mayo Clinic

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94116
        • University of California, San Francisco
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Symptomatic outcomes measured by validated instruments
Time Frame: At baseline, 6 weeks and 6, 12, 24, and 36 months following treatment.
At baseline, 6 weeks and 6, 12, 24, and 36 months following treatment.

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events following treatment
Time Frame: At baseline, 6 weeks and 6, 12, 24 and 36 months following treatment.
At baseline, 6 weeks and 6, 12, 24 and 36 months following treatment.
Biologic predictors of outcome
Time Frame: Blood sample is obtained at baseline and at 12, 24, and 36 months following treatment
Blood sample is obtained at baseline and at 12, 24, and 36 months following treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

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

Investigators

  • Principal Investigator: Elizabeth A. Stewart, M.D., Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2010

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

October 13, 2009

First Submitted That Met QC Criteria

October 14, 2009

First Posted (Estimate)

October 15, 2009

Study Record Updates

Last Update Posted (Actual)

January 12, 2018

Last Update Submitted That Met QC Criteria

January 10, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-005095
  • 1RC1HD063312-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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