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

Primary Purpose

Symptomatic Uterine Leiomyomas, Fibroids, Uterine Fibroids

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Focused ultrasound (MRgFUS)

Uterine artery embolization (UAE)

About this trial

This is an interventional treatment trial for Symptomatic Uterine Leiomyomas focused on measuring Uterine fibroids, Fibroids, Uterine leiomyomas, UAE, UFE, Magnetic resonance guided focused ultrasound, MRgFUS, Pelvic pain

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

University of California, San Francisco
Mayo Clinic
Duke University Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Focused Ultrasound (MRgFUS)

Uterine Artery Embolization (UAE)

Arm Description

Outcomes

Primary Outcome Measures

Symptomatic outcomes measured by validated instruments

Secondary Outcome Measures

Adverse events following treatment

Biologic predictors of outcome

Full Information

NCT ID

NCT00995878

First Posted

October 13, 2009

Last Updated

January 10, 2018

Sponsor

Mayo Clinic

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT00995878

Brief Title

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

Official Title

The FIRSTT Study: Comparing Focused Ultrasound and Uterine Artery Embolization for Uterine Fibroids

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

April 29, 2010 (Actual)

Primary Completion Date

December 2016 (Actual)

Study Completion Date

December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

Collaborators

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

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Symptomatic Uterine Leiomyomas, Fibroids, Uterine Fibroids, Myomas

Keywords

Uterine fibroids, Fibroids, Uterine leiomyomas, UAE, UFE, Magnetic resonance guided focused ultrasound, MRgFUS, Pelvic pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

56 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Focused Ultrasound (MRgFUS)

Arm Type

Active Comparator

Arm Title

Uterine Artery Embolization (UAE)

Arm Type

Active Comparator

Intervention Type

Procedure

Intervention Name(s)

Focused ultrasound (MRgFUS)

Other Intervention Name(s)

ExAblate 2000

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Uterine artery embolization (UAE)

Other Intervention Name(s)

Uterine Fibroid Embolization, UFE

Intervention Description

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.

Primary Outcome Measure Information:

Title

Symptomatic outcomes measured by validated instruments

Time Frame

At baseline, 6 weeks and 6, 12, 24, and 36 months following treatment.

Secondary Outcome Measure Information:

Title

Adverse events following treatment

Time Frame

At baseline, 6 weeks and 6, 12, 24 and 36 months following treatment.

Title

Biologic predictors of outcome

Time Frame

Blood sample is obtained at baseline and at 12, 24, and 36 months following treatment

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Elizabeth A. Stewart, M.D.

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of California, San Francisco

City

San Francisco

State/Province

California

ZIP/Postal Code

94116

Country

United States

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

Duke University Health System

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27705

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

34242085

Citation

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.

Results Reference

derived

PubMed Identifier

30696556

Citation

Laughlin-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.

Results Reference

derived

PubMed Identifier

28063909

Citation

Barnard 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.

Results Reference

derived

PubMed Identifier

27073063

Citation

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, 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.

Results Reference

derived

PubMed Identifier

25989973

Citation

Laughlin-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.

Results Reference

derived

PubMed Identifier

21794858

Citation

Bouwsma 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.

Results Reference

derived

Links:

URL

http://www.nichd.nih.gov/

Description

National Institute of Child Health and Human Development

URL

http://www.mayoclinic.com/health/uterine-fibroids/DS00078

Description

Mayo Clinic Uterine Fibroids Information

URL

http://www.radiologyinfo.org/en/info.cfm?pg=ufe

Description

Radiology Society of North America Information on UFE

URL

http://on.fb.me/gewuoO

Description

Mayo Clinic Uterine Fibroid Facebook page sharing educational information related to fibroids.

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

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