The FIRSTT: Comparing MRgFUS(MR-guided Focused Ultrasound) Versus UAE (Uterine Artery Embolization)for Uterine Fibroids.
The FIRSTT Study: Comparing Focused Ultrasound and Uterine Artery Embolization for Uterine Fibroids
2 other identifiers
interventional
56
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Apr 2010
Longer than P75 for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 13, 2009
CompletedFirst Posted
Study publicly available on registry
October 15, 2009
CompletedStudy Start
First participant enrolled
April 29, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedJanuary 12, 2018
January 1, 2018
6.6 years
October 13, 2009
January 10, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Symptomatic outcomes measured by validated instruments
At baseline, 6 weeks and 6, 12, 24, and 36 months following treatment.
Secondary Outcomes (2)
Adverse events following treatment
At baseline, 6 weeks and 6, 12, 24 and 36 months following treatment.
Biologic predictors of outcome
Blood sample is obtained at baseline and at 12, 24, and 36 months following treatment
Study Arms (2)
Focused Ultrasound (MRgFUS)
ACTIVE COMPARATORUterine Artery Embolization (UAE)
ACTIVE COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
University of California, San Francisco
San Francisco, California, 94116, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Duke University Health System
Durham, North Carolina, 27705, United States
Related Publications (6)
Laughlin-Tommaso SK, Gorny KR, Hesley GK, Vaughan LE, Woodrum DA, Lemens MA, Stewart EA. Uterine and Fibroid Imaging Analysis from the FIRSTT Study. J Womens Health (Larchmt). 2022 Apr;31(4):546-554. doi: 10.1089/jwh.2020.8892. Epub 2021 Jul 8.
PMID: 34242085DERIVEDLaughlin-Tommaso S, Barnard EP, AbdElmagied AM, Vaughan LE, Weaver AL, Hesley GK, Woodrum DA, Jacoby VL, Kohi MP, Price TM, Nieves A, Miller MJ, Borah BJ, Moriarty JP, Gorny KR, Leppert PC, Severson AL, Lemens MA, Stewart EA. FIRSTT study: randomized controlled trial of uterine artery embolization vs focused ultrasound surgery. Am J Obstet Gynecol. 2019 Feb;220(2):174.e1-174.e13. doi: 10.1016/j.ajog.2018.10.032. Epub 2018 Oct 26.
PMID: 30696556DERIVEDBarnard EP, AbdElmagied AM, Vaughan LE, Weaver AL, Laughlin-Tommaso SK, Hesley GK, Woodrum DA, Jacoby VL, Kohi MP, Price TM, Nieves A, Miller MJ, Borah BJ, Gorny KR, Leppert PC, Peterson LG, Stewart EA. Periprocedural outcomes comparing fibroid embolization and focused ultrasound: a randomized controlled trial and comprehensive cohort analysis. Am J Obstet Gynecol. 2017 May;216(5):500.e1-500.e11. doi: 10.1016/j.ajog.2016.12.177. Epub 2017 Jan 5.
PMID: 28063909DERIVEDAbdElmagied AM, Vaughan LE, Weaver AL, Laughlin-Tommaso SK, Hesley GK, Woodrum DA, Jacoby VL, Kohi MP, Price TM, Nieves A, Miller MJ, Borah BJ, Gorny KR, Leppert PC, Lemens MA, Stewart EA. Fibroid interventions: reducing symptoms today and tomorrow: extending generalizability by using a comprehensive cohort design with a randomized controlled trial. Am J Obstet Gynecol. 2016 Sep;215(3):338.e1-338.e18. doi: 10.1016/j.ajog.2016.04.001. Epub 2016 Apr 9.
PMID: 27073063DERIVEDLaughlin-Tommaso SK, Borah BJ, Stewart EA. Effect of menses on standardized assessment of sexual dysfunction among women with uterine fibroids: a cohort study. Fertil Steril. 2015 Aug;104(2):435-9. doi: 10.1016/j.fertnstert.2015.04.029. Epub 2015 May 16.
PMID: 25989973DERIVEDBouwsma EV, Hesley GK, Woodrum DA, Weaver AL, Leppert PC, Peterson LG, Stewart EA. Comparing focused ultrasound and uterine artery embolization for uterine fibroids-rationale and design of the Fibroid Interventions: reducing symptoms today and tomorrow (FIRSTT) trial. Fertil Steril. 2011 Sep;96(3):704-10. doi: 10.1016/j.fertnstert.2011.06.062. Epub 2011 Jul 27.
PMID: 21794858DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elizabeth A. Stewart, M.D.
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Obstetrics and Gynecology
Study Record Dates
First Submitted
October 13, 2009
First Posted
October 15, 2009
Study Start
April 29, 2010
Primary Completion
December 1, 2016
Study Completion
December 1, 2017
Last Updated
January 12, 2018
Record last verified: 2018-01