Symptomatic Uterine LeiomyomasPhase 4NCT00995878
The FIRSTT: Comparing MRgFUS(MR-guided Focused Ultrasound) Versus UAE (Uterine Artery Embolization)for Uterine Fibroids.
A Phase 4 study testing Focused ultrasound (MRgFUS) and Uterine artery embolization (UAE) in people with Symptomatic Uterine Leiomyomas and Fibroids, run by Mayo Clinic at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 years and older, women only
- Conditions the study is for
- Symptomatic Uterine Leiomyomas, Fibroids, Uterine Fibroids
- What is being tested?
- Focused ultrasound (MRgFUS) and Uterine artery embolization (UAE)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 3 sitesUnited States
- Study dates
- 29 Apr 2010to Dec 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Duke University Health System
Durham, North Carolina, 27705
Mayo Clinic
Rochester, Minnesota, 55905
University of California, San Francisco
San Francisco, California, 94116
About this study
Official title: The FIRSTT Study: Comparing Focused Ultrasound and Uterine Artery Embolization for Uterine Fibroids
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.
Read more
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.
Read the 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.
- Conditions
- Symptomatic Uterine Leiomyomas, Fibroids, Uterine Fibroids, Myomas
- Being tested
- Focused ultrasound (MRgFUS), Uterine artery embolization (UAE)
- Keywords
- Uterine fibroids, Fibroids, Uterine leiomyomas, UAE, UFE, Magnetic resonance guided focused ultrasound, MRgFUS, Pelvic pain
- Medical subject headings
- Leiomyoma, Myoma, Myofibroma, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focused ultrasound (MRgFUS)Procedure or surgery
Also called ExAblate 2000
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.
Uterine artery embolization (UAE)Procedure or surgery
Also called Uterine Fibroid Embolization, UFE
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.
| Study group | Role | What they receive |
|---|---|---|
| Focused Ultrasound (MRgFUS) | Active comparator | Not described Receives: Procedure: Focused ultrasound (MRgFUS) |
| Uterine Artery Embolization (UAE) | Active comparator | Not described Receives: Procedure: Uterine artery embolization (UAE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptomatic outcomes measured by validated instruments
Measured: At baseline, 6 weeks and 6, 12, 24, and 36 months following treatment.
Secondary outcomes (2)
Adverse events following treatment
Measured: At baseline, 6 weeks and 6, 12, 24 and 36 months following treatment.
Biologic predictors of outcome
Measured: Blood sample is obtained at baseline and at 12, 24, and 36 months following treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2009 (estimated)
- Study start29 Apr 2010
- Primary completionDec 2016
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Symptomatic Uterine LeiomyomasStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Elizabeth A. Stewart, Mayo Clinic
- Investigators
- Elizabeth A. Stewart, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00995878
- Sponsor's protocol ID
- 09-005095
- Other IDs
- 1RC1HD063312-01
- Status last verified
- Jan 2018
- First submitted
- 13 Oct 2009
- Last updated
- 12 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 34242085Laughlin-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.
PubMed 30696556Barnard 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.
PubMed 28063909AbdElmagied 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.
PubMed 27073063Laughlin-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.
PubMed 25989973Bouwsma 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.
PubMed 21794858
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The FIRSTT Study: Comparing Focused Ultrasound and Uterine Artery Embolization for Uterine Fibroids
- ClinicalTrials.gov ID
- NCT00995878
- Acronym / sponsor ID
- 09-005095
- Conditions
- Symptomatic Uterine Leiomyomas, Fibroids, Uterine Fibroids, Myomas
- Keywords
- Uterine fibroids, Fibroids, Uterine leiomyomas, UAE, UFE, Magnetic resonance guided focused ultrasound, MRgFUS, Pelvic pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 29 Apr 2010 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 15 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Focused Ultrasound (MRgFUS) | Active comparator | Procedure: Focused ultrasound (MRgFUS) |
| Uterine Artery Embolization (UAE) | Active comparator | Procedure: Uterine artery embolization (UAE) |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focused ultrasound (MRgFUS)Also: ExAblate 2000MRgFUS 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. | Procedure or surgery | Focused Ultrasound (MRgFUS) |
| Uterine artery embolization (UAE)Also: Uterine Fibroid Embolization, UFEUAE 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. | Procedure or surgery | Uterine Artery Embolization (UAE) |
Primary outcome
Symptomatic outcomes measured by validated instruments
Time frame: At baseline, 6 weeks and 6, 12, 24, and 36 months following treatment.
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2018.
- Derived from this study: PubMed 34242085Laughlin-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.
- Derived from this study: PubMed 30696556Laughlin-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.
- Derived from this study: PubMed 28063909Barnard 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.
- Derived from this study: PubMed 27073063AbdElmagied 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.
- Derived from this study: PubMed 25989973Laughlin-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.
- Derived from this study: PubMed 21794858Bouwsma 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.
- National Institute of Child Health and Human DevelopmentLink provided by the sponsor.
- Radiology Society of North America Information on UFELink provided by the sponsor.
- Mayo Clinic Uterine Fibroid Facebook page sharing educational information related to fibroids.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth A. Stewart, M.D. principal investigator
Mayo Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Focused ultrasound (MRgFUS) and Uterine artery embolization (UAE) in people with Symptomatic Uterine Leiomyomas and Fibroids, run by Mayo Clinic at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptomatic outcomes measured by validated instruments (time frame: At baseline, 6 weeks and 6, 12, 24, and 36 months following treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00995878, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2018.