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Uterine LeiomyomaPhase 3NCT02736435

Treatment of Uterine Fibroids With Magnetic Resonance Guided High Intensity Focused Ultrasound

A Phase 3 study testing Magnetic Resonance Guided High Intensity Focused Ultrasound and leuprolide acetate for depot suspension in people with Uterine Leiomyoma, run by Thunder Bay Regional Health Research Institute at 1 site in Canada.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this study is to demonstrate the effectiveness of MR-HIFU for the treatment of uterine fibroids in Northwestern Ontario, which is a rural and remote setting. Read more about this study

Who is it for?
Ages 18 to 50 years, women only
Conditions the study is for
Uterine Leiomyoma
What is being tested?
Magnetic Resonance Guided High Intensity Focused Ultrasound and leuprolide acetate for depot suspension
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteCanada
Study dates
18 Jan 2018to 18 Jan 2018
Phase
Phase 3
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 18 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Women aged 18 to 50 years
  • Weight <140kg
  • Pre or perimenopausal
  • Uterine size <24 weeks
  • Cervical screen by Pap test: Normal, Low Grade Squamous Intraepithelial Lesion, or Atypical Squamous Cells of Undetermined Significance as per Cancer Care Ontario guidelines
  • Transformed symptom severity score ≥40
Show all 22Show fewer
  • Willing to attend all study visits
  • Willing to complete evaluation forms
  • Willing and able to use reliable contraception;
  • MR-HIFU Criteria Trial Arm 1:
  • Minimum of 50% of fibroid volume accessible for treatment
  • Dominant fibroid ≤8 cm
  • Uterine volume <900 cc
  • Total fibroid treatment volume <250 cc
  • No more than 5 fibroids planned for ablation
  • Completely non-enhancing fibroids should not be treated
  • MR-HIFU Criteria Trial Arm 2:
  • Minimum of 50% of fibroid volume accessible for treatment
  • Dominant fibroid >8 cm or uterine volume >900 cc
  • Total fibroid treatment volume <250 cc
  • No more than 5 fibroids planned for ablation
  • Completely non-enhancing fibroids should not be treated

Who cannot join

  • Other pelvic disease (endometriosis, ovarian tumor, acute pelvic disease, other mass)
  • Significant systemic disease even if well controlled
  • Positive pregnancy test
  • Abnormal uterine bleeding (participant can be included if an endometrial biopsy confirms no hyperplasia or malignancy in the past 6 months)
  • Extensive scarring along anterior abdominal wall (>50% of area)
  • Surgical clips or scar tissue in the path of the MR-HIFU beam
Show all 11Show fewer
  • MRI contraindicated according to standard operating procedure
  • MRI contrast contraindicated (including renal insufficiency)
  • Calcifications around or throughout uterine tissues
  • Fibroids not quantifiable on MRI
  • Highly perfused or brighter than myometrium in T2-weighted MRI fibroids (Type 3 fibroids).

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Thunder Bay Regional Health Sciences Centre

    Thunder Bay, Ontario, P7B 6V4

Other trials in Canada

About this study

The purpose of this study is to demonstrate the effectiveness of MR-HIFU for the treatment of uterine fibroids in Northwestern Ontario, which is a rural and remote setting.

Read the detailed description

Uterine fibroids are benign smooth muscle tumours of the muscular wall of the uterus that affect 40 per cent of women. While the majority of fibroids are asymptomatic, fibroids may cause menorrhagia, bulk symptoms (i.e. ureteric obstruction, urinary frequency and urgency, bowel dysfunction), pain and in certain instances infertility.

Magnetic resonance image-guided high-intensity focused ultrasound (MR-HIFU) treatment of fibroids is an established method for symptom alleviation with over 3000 women receiving treatment worldwide. MR-HIFU is a non-invasive, non-surgical procedure that uses ultrasound energy to thermally ablate the fibroid leading to a reduction in bleeding and in the size of uterine fibroids over time. MR-HIFU it is not currently being used for the treatment of symptomatic fibroids in Canada.

The Thunder Bay Regional Research Institute has one of the first clinically available MR-HIFU equipment in Canada. In order to bring this technology into clinical practice, a knowledge translation study is needed to demonstrate that MR-HIFU can treat symptomatic uterine fibroids as successfully in Northwestern Ontario compared to urban centres where all of the clinical trials have been conducted. The ability to screen and follow up women treated with MR-HIFU with ultrasound rather than MRI would allow participants to receive follow up in regional centres in Northwestern Ontario and it would be more cost effective from a health system perspective. In addition, more research is needed to broaden the scope of treatment to include fibroids greater than 8 cm such that more women could benefit from this non-surgical fibroid management option.

Being tested
Magnetic Resonance Guided High Intensity Focused Ultrasound, leuprolide acetate for depot suspension
Keywords
Magnetic Resonance Guided High Intensity Focused Ultrasound, MR-HIFU, Fibroids, Leuprolide Acetate
Medical subject headings
Myofibroma, Leiomyoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Magnetic Resonance Guided High Intensity Focused UltrasoundDevice

    Also called MR-HIFU

    Direct treatment of uterine fibroids with MR-HIFU

  • leuprolide acetate for depot suspensionDrug

    Also called Lupron Depot

    Treatment of uterine fibroids with leuprolide acetate prior to MR-HIFU

Study groups in NCT02736435
Study groupRoleWhat they receive
Fibroid dimension < 8 cmExperimentalWomen with a maximum fibroid dimension less than 8 cm and a total uterine volume less than 900 cc. Intervention: Treatment of fibroids with Magnetic Resonance Guided High Intensity Focused Ultrasound.
Receives: Device: Magnetic Resonance Guided High Intensity Focused Ultrasound
Fibroid dimension > 8 cmExperimentalWomen with a maximum fibroid dimension greater than 8 cm or a total uterine volume greater than 900 cc. Intervention A: Pre-treated with 11.25mg leuprolide acetate for depot suspension for 3 months to reduce size of fibroids. Intervention B: Treatment with Magnetic Resonance Guided High Intensity Focused Ultrasound if fibroids decrease to treatable size of less than 8cm and uterine volume less than 900cc.
Receives: Device: Magnetic Resonance Guided High Intensity Focused Ultrasound; Drug: leuprolide acetate for depot suspension

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in uterine fibroid symptom severity scale

    Assessing change from baseline value

    Measured: 3, 6, and 12 months

Secondary outcomes (8)

  1. Change in short form McGill pain questionnaire

    Assessing change from baseline value

    Measured: 24h, 72h, 6week, 3, 6, and 12 month

  2. Change in pictorial blood loss assessment chart

    Assessing change from baseline value

    Measured: 3, 6, and 12 months

  3. Change in uterine fibroid symptom and health-related quality of life questionnaire

    Assessing change from baseline value

    Measured: 12 months

  4. Participant use of alternative therapies for treatment of fibroids

    Questionnaire to assess if participants are selecting to use alternative treatments for relief of symptoms of uterine fibroids.

    Measured: 6 weeks, 3, 6, and 12 months

  5. MR Imaging to assess change in fibroid volume.

    Assessing change from baseline value

    Measured: 3, 6, and 12 months

  6. MR Imaging to assess change in perfusion.

    Assessing change from baseline value

    Measured: 3, 6, and 12 months

  7. Ultrasound imaging to assess change in fibroid volume.

    Assessing change from baseline value

    Measured: 3, 6, and 12 months

  8. Ultrasound imaging to assess change in fibroid perfusion.

    Assessing change from baseline value

    Measured: 3, 6, and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2016 (estimated)
  2. Study start18 Jan 2018
  3. Primary completion18 Jan 2018
  4. Study completion18 Jan 2018

Why it stopped: Lengthy delays and inadequate support to proceed.

Resources

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 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02736435
Sponsor's protocol ID
RP-317-07302014
Status last verified
Apr 2017
First submitted
18 Mar 2016
Last updated
6 Feb 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Friedman AJ, Hoffman DI, Comite F, Browneller RW, Miller JD. Treatment of leiomyomata uteri with leuprolide acetate depot: a double-blind, placebo-controlled, multicenter study. The Leuprolide Study Group. Obstet Gynecol. 1991 May;77(5):720-5.

    PubMed 1901638

  • Gizzo S, Saccardi C, Patrelli TS, Ancona E, Noventa M, Fagherazzi S, Mozzanega B, D'Antona D, Nardelli GB. Magnetic resonance-guided focused ultrasound myomectomy: safety, efficacy, subsequent fertility and quality-of-life improvements, a systematic review. Reprod Sci. 2014 Apr;21(4):465-76. doi: 10.1177/1933719113497289. Epub 2013 Jul 18.

    PubMed 23868442

  • Quinn SD, Vedelago J, Gedroyc W, Regan L. Safety and five-year re-intervention following magnetic resonance-guided focused ultrasound (MRgFUS) for uterine fibroids. Eur J Obstet Gynecol Reprod Biol. 2014 Nov;182:247-51. doi: 10.1016/j.ejogrb.2014.09.039. Epub 2014 Oct 6.

    PubMed 25445107

  • Smart OC, Hindley JT, Regan L, Gedroyc WG. Gonadotrophin-releasing hormone and magnetic-resonance-guided ultrasound surgery for uterine leiomyomata. Obstet Gynecol. 2006 Jul;108(1):49-54. doi: 10.1097/01.AOG.0000222381.94325.4f.

    PubMed 16816055

  • Stewart EA, Gostout B, Rabinovici J, Kim HS, Regan L, Tempany CM. Sustained relief of leiomyoma symptoms by using focused ultrasound surgery. Obstet Gynecol. 2007 Aug;110(2 Pt 1):279-87. doi: 10.1097/01.AOG.0000275283.39475.f6.

    PubMed 17666601

  • Thiburce AC, Frulio N, Hocquelet A, Maire F, Salut C, Balageas P, Bouzgarrou M, Hocke C, Trillaud H. Magnetic resonance-guided high-intensity focused ultrasound for uterine fibroids: Mid-term outcomes of 36 patients treated with the Sonalleve system. Int J Hyperthermia. 2015;31(7):764-70. doi: 10.3109/02656736.2015.1063169. Epub 2015 Sep 14.

    PubMed 26367772

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Magnetic Resonance Guided High Intensity Focused Ultrasound and leuprolide acetate for depot suspension in people with Uterine Leiomyoma, run by Thunder Bay Regional Health Research Institute at 1 site in Canada.

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 22 inclusion and 11 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: withdrawn, as of the sponsor's last update on 6 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 was withdrawn before enrolling participants, so there are no results.

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?

Change in uterine fibroid symptom severity scale (time frame: 3, 6, and 12 months). 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 NCT02736435, 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 6 Feb 2018; AzTrials last refreshed its copy on 8 Nov 2026.

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