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

Primary Purpose

Uterine Leiomyoma

Status

Withdrawn

Phase

Phase 3

Locations

Canada

Study Type

Interventional

Intervention

Magnetic Resonance Guided High Intensity Focused Ultrasound

leuprolide acetate for depot suspension

About this trial

This is an interventional treatment trial for Uterine Leiomyoma focused on measuring Magnetic Resonance Guided High Intensity Focused Ultrasound, MR-HIFU, Fibroids, Leuprolide Acetate

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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
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

Exclusion Criteria:

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
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).

Sites / Locations

Thunder Bay Regional Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Fibroid dimension < 8 cm

Fibroid dimension > 8 cm

Arm Description

Women 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.

Women 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.

Outcomes

Primary Outcome Measures

Change in uterine fibroid symptom severity scale

Assessing change from baseline value

Secondary Outcome Measures

Change in short form McGill pain questionnaire

Assessing change from baseline value

Change in pictorial blood loss assessment chart

Assessing change from baseline value

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

Assessing change from baseline value

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.

MR Imaging to assess change in fibroid volume.

Assessing change from baseline value

MR Imaging to assess change in perfusion.

Assessing change from baseline value

Ultrasound imaging to assess change in fibroid volume.

Assessing change from baseline value

Ultrasound imaging to assess change in fibroid perfusion.

Assessing change from baseline value

Full Information

NCT ID

NCT02736435

First Posted

March 18, 2016

Last Updated

February 2, 2018

Sponsor

Thunder Bay Regional Health Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT02736435

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Withdrawn

Why Stopped

Lengthy delays and inadequate support to proceed.

Study Start Date

January 18, 2018 (Actual)

Primary Completion Date

January 18, 2018 (Actual)

Study Completion Date

January 18, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Thunder Bay Regional Health Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

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

Uterine Leiomyoma

Keywords

Magnetic Resonance Guided High Intensity Focused Ultrasound, MR-HIFU, Fibroids, Leuprolide Acetate

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fibroid dimension < 8 cm

Arm Type

Experimental

Arm Description

Arm Title

Fibroid dimension > 8 cm

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Magnetic Resonance Guided High Intensity Focused Ultrasound

Other Intervention Name(s)

MR-HIFU

Intervention Description

Direct treatment of uterine fibroids with MR-HIFU

Intervention Type

Drug

Intervention Name(s)

leuprolide acetate for depot suspension

Other Intervention Name(s)

Lupron Depot

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in uterine fibroid symptom severity scale

Description

Assessing change from baseline value

Time Frame

3, 6, and 12 months

Secondary Outcome Measure Information:

Title

Change in short form McGill pain questionnaire

Description

Assessing change from baseline value

Time Frame

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

Title

Change in pictorial blood loss assessment chart

Description

Assessing change from baseline value

Time Frame

3, 6, and 12 months

Title

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

Description

Assessing change from baseline value

Time Frame

12 months

Title

Participant use of alternative therapies for treatment of fibroids

Description

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

Time Frame

6 weeks, 3, 6, and 12 months

Title

MR Imaging to assess change in fibroid volume.

Description

Assessing change from baseline value

Time Frame

3, 6, and 12 months

Title

MR Imaging to assess change in perfusion.

Description

Assessing change from baseline value

Time Frame

3, 6, and 12 months

Title

Ultrasound imaging to assess change in fibroid volume.

Description

Assessing change from baseline value

Time Frame

3, 6, and 12 months

Title

Ultrasound imaging to assess change in fibroid perfusion.

Description

Assessing change from baseline value

Time Frame

3, 6, and 12 months

Other Pre-specified Outcome Measures:

Title

Return to activity within 72 hours of treatment

Time Frame

72 hours

Title

Change in hemoglobin level

Description

Assessing change from baseline value

Time Frame

3, 6, and 12 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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 Exclusion Criteria: 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 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Naana A Jumah, MD DPhil FRCSC

Organizational Affiliation

Northern Ontario School of Medicine, Thunder Bay Regional Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Thunder Bay Regional Health Sciences Centre

City

Thunder Bay

State/Province

Ontario

ZIP/Postal Code

P7B 6V4

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

1901638

Citation

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.

Results Reference

background

PubMed Identifier

23868442

Citation

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.

Results Reference

background

PubMed Identifier

25445107

Citation

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.

Results Reference

background

PubMed Identifier

16816055

Citation

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.

Results Reference

background

PubMed Identifier

17666601

Citation

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.

Results Reference

background

PubMed Identifier

26367772

Citation

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.

Results Reference

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

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