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

NCT02736435 | Withdrawn Phase 3 DMC FDA Drug

• 1 other identifier: RP-317-07302014
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Uterine Leiomyoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in uterine fibroid symptom severity scale

  Assessing change from baseline value

  3, 6, and 12 months

Secondary Outcomes (8)

• Change in short form McGill pain questionnaire

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

• Change in pictorial blood loss assessment chart

  3, 6, and 12 months

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

  12 months

• Participant use of alternative therapies for treatment of fibroids

  6 weeks, 3, 6, and 12 months

• MR Imaging to assess change in fibroid volume.

  3, 6, and 12 months

Other Outcomes (2)

• Return to activity within 72 hours of treatment

  72 hours

• Change in hemoglobin level

  3, 6, and 12 months

Study Arms (2)

Fibroid dimension < 8 cm

EXPERIMENTAL

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.

Device: Magnetic Resonance Guided High Intensity Focused Ultrasound

Fibroid dimension > 8 cm

EXPERIMENTAL

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.

Device: Magnetic Resonance Guided High Intensity Focused Ultrasound; Drug: leuprolide acetate for depot suspension

Interventions

Magnetic Resonance Guided High Intensity Focused Ultrasound DEVICE

Direct treatment of uterine fibroids with MR-HIFU

Also known as: MR-HIFU

Fibroid dimension < 8 cm; Fibroid dimension > 8 cm

leuprolide acetate for depot suspension DRUG

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

Also known as: Lupron Depot

Fibroid dimension > 8 cm

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Thunder Bay Regional Health Research Institute: lead

Study Sites (1)

Thunder Bay Regional Health Sciences Centre

Thunder Bay, Ontario, P7B 6V4, Canada

Location

Related Publications (6)

• 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.

  PMID: 1901638 BACKGROUND

• 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.

  PMID: 23868442 BACKGROUND

• 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.

  PMID: 25445107 BACKGROUND

• 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.

  PMID: 16816055 BACKGROUND

• 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.

  PMID: 17666601 BACKGROUND

• 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.

  PMID: 26367772 BACKGROUND

MeSH Terms

Conditions

Myofibroma; Leiomyoma

Interventions

Leuprolide

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Neoplasms, Muscle Tissue

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Naana A Jumah, MD DPhil FRCSC

  Northern Ontario School of Medicine, Thunder Bay Regional Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2016
• First Posted: April 13, 2016
• Study Start: January 18, 2018
• Primary Completion: January 18, 2018
• Study Completion: January 18, 2018
• Last Updated: February 6, 2018

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)