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The FIRSTT: Comparing MRgFUS(MR-guided Focused Ultrasound) Versus UAE (Uterine Artery Embolization)for Uterine Fibroids.
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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 Intervention Model: Parallel Assignment Masking: No masking Primary Purpose: Treatment |
| Official Title: | The FIRSTT Study: Comparing Focused Ultrasound and Uterine Artery Embolization for Uterine Fibroids |
- Symptomatic outcomes measured by validated instruments [ Time Frame: At baseline, 6 weeks and 6, 12, 24, and 36 months following treatment. ]
- Adverse events following treatment [ Time Frame: 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 ]
| Estimated Enrollment: | 180 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | December 2017 |
| Primary Completion Date: | December 2016 (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:
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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 (Adult, Senior) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Women able to give informed consent and willing and able to attend all study visits
- Premenopausal women at least 25 years of age
- No evidence of High Grade SIL by pap smears or HPV testing within institutional guidelines.
Exclusion Criteria:
- Women actively trying for pregnancy or currently pregnant
- Uterine size > 20 weeks
- 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.
- More than 6 fibroids > than 3 centimeters in maximal diameter
- Allergy to either gadolinium or iodinated contrast
- Implanted metallic device prohibiting MRI
- Severe claustrophobia
- BMI which prohibits subject from fitting in MRI device
- Severe abdominal scarring precluding safe MRgFUS treatment
- Active pelvic infection
- Intrauterine contraceptive device in place at the time of treatment
- Current use of GnRH agonists or antagonists
- Unstable medical conditions requiring additional monitoring during the procedure
- Bleeding diathesis requiring medical treatment
- Imaging suggestive of malignant disease of uterus, ovary, or cervix
- Imaging suggestive of only adenomyosis
- Pedunculated submucosal or subserosal myoma with a stalk less than 25% of the maximal fibroid diameter
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00995878
| 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 | |
| Principal Investigator: | Elizabeth A. Stewart, M.D. | Mayo Clinic |
More Information
Additional Information:
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 ( U.S. NIH Grant/Contract ) |
| Study First Received: | October 13, 2009 |
| Last Updated: | March 23, 2017 |
Keywords provided by Elizabeth A. Stewart, Mayo Clinic:
|
Uterine fibroids Fibroids Uterine leiomyomas UAE |
UFE Magnetic resonance guided focused ultrasound MRgFUS Pelvic pain |
Additional relevant MeSH terms:
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Leiomyoma Myofibroma 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 16, 2017