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

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Rochester, Minn. Mayo Clinic principal investigator Elizabeth Stewart, M.D.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

Elizabeth Stewart, M.D.

Closed for enrollment

More information

Publications

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