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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Elizabeth A. Stewart, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00995878
First received: October 13, 2009
Last updated: August 6, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Symptomatic Uterine Leiomyomas
Fibroids
Uterine Fibroids
Myomas
Procedure: Focused ultrasound (MRgFUS)
Procedure: Uterine artery embolization (UAE)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The FIRSTT Study: Comparing Focused Ultrasound and Uterine Artery Embolization for Uterine Fibroids

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Symptomatic outcomes measured by validated instruments [ Time Frame: At baseline, 6 weeks and 6, 12, 24, and 36 months following treatment. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events following treatment [ Time Frame: At baseline, 6 weeks and 6, 12, 24 and 36 months following treatment. ] [ Designated as safety issue: Yes ]
  • Biologic predictors of outcome [ Time Frame: Blood sample is obtained at baseline and at 12, 24, and 36 months following treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: October 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

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.

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00995878

Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94116
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, North Carolina
Duke University Health System
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Elizabeth A. Stewart, M.D. Mayo Clinic
  More Information

Additional Information:
No publications provided by Mayo Clinic

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Elizabeth A. Stewart, Professor of Obstetrics and Gynecology, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00995878     History of Changes
Other Study ID Numbers: 09-005095, 1RC1HD063312-01
Study First Received: October 13, 2009
Last Updated: August 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Uterine fibroids
Fibroids
Uterine leiomyomas
UAE
UFE
Magnetic resonance guided focused ultrasound
MRgFUS
Pelvic pain

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Myoma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases

ClinicalTrials.gov processed this record on August 21, 2014