Therapeutic Magnetic Resonance Imaging (MRI)-Guided High Intensity Focused Ultrasound (HIFU) Ablation of Uterine Fibroids

NCT00897897 | Completed Results DMC

• 1 other identifier: 996233
• Study Type: interventional
• Target: 33
• Locations: 4 countries
• Sites: 4

Brief Summary

This study is to confirm the safety and technical effectiveness of MRI guided High Intensity Focused Ultrasound (HIFU) in ablating uterine tissue associated with symptomatic leiomyomas. The importance of this therapy is that it offers a non-invasive, uterine sparing procedure for the treatment of uterine fibroids in pre- and peri- menopausal women. MRI guided high intensity focused ultrasound uses ultrasound to heat and thermally ablate fibroid tissue. The MRI system identifies the ultrasound path and monitors heat rise in the fibroid tissue. The goal of the study is to show treatment safety and technical effectiveness. MR-guided HIFU will be performed in patients who pass inclusion/exclusion criteria. Safety, quality of life, and imaging endpoints will be evaluated in all study patients. The goal of this study is to demonstrate that:

1. 1.The safety profile is acceptable (safety)
2. 2.Actual MR-HIFU ablated volumes (as measured with contrast enhanced MRI) match the intended volumes (technical effectiveness)
3. 3.When intended, volumes greater than 20% of the fibroid volume can be successfully ablated (technical effectiveness)

Conditions

Uterine Fibroids

Keywords

Uterine Leiomyomas; Fibroids; HIFU; Ablation; High Intensity Focused Ultrasound

Outcome Measures

Primary Outcomes (1)

• Adverse Events/Subject Resulting From HIFU Treatment of the Uterine Fibroids

  The number of Adverse Events reported during the study, divided by the total number of treated subjects. This corresponds to the mean number of Adverse Events per subject.

  30 days after treatment

Secondary Outcomes (1)

• Fibroid Symptom Severity Score (SSS) From the Uterine Fibroid Symptoms - Quality of Life (UFS-QoL) Questionnaire.

  At baseline and at 30 days following treatment

Study Arms (1)

Treated leiomyomas

OTHER

Pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure receive a treatment with the Philips MRI-guided HIFU system. Patients must have completed child bearing prior to enrolling in this study.

Device: Philips MRI-guided HIFU system

Interventions

Philips MRI-guided HIFU system DEVICE

HIFU is the use of focused ultrasound energy to penetrate through soft tissue and causes localized high temperatures (55°C to 70°C) for a few seconds within the target producing well defined regions of protein denaturation, irreversible cell damage, and coagulative necrosis.

Also known as: Sonalleve

Treated leiomyomas

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women, age between 18 and 59 years
• Weight \< 140kg
• Pre- or peri-menopausal
• Uterine size \< 24 weeks
• Transformed SSS score \> 40
• Normal Cervical cell assessment by PAP
• Symptomatic Fibroid disease
• Dominant fibroid greater than or equal to 3cm and less than or equal to 12 cm

You may not qualify if:

• Other Pelvic Disease
• Desire for future pregnancy
• Significant systemic disease even if controlled
• Positive pregnancy test
• Hematocrit \< 25%
• Scarring or other interference of the HIFU beam
• MRI or contrast contraindicated
• Fibroids not quantifiable on MRI
• Calcifications around or throughout uterine tissues
• Communication barrier

Sponsors & Collaborators

• Philips Healthcare: lead
• Philips Medical Systems: collaborator

Study Sites (4)

Hospital St. Andre

Bordeaux, France

Location

University Hospital Schleswig-Holstein

Lübeck, Germany

Location

University Medical Center

Utrecht, Netherlands

Location

Samsung Medical Center

Seoul, South Korea

Location

Related Publications (8)

• Spies JB, Coyne K, Guaou Guaou N, Boyle D, Skyrnarz-Murphy K, Gonzalves SM. The UFS-QOL, a new disease-specific symptom and health-related quality of life questionnaire for leiomyomata. Obstet Gynecol. 2002 Feb;99(2):290-300. doi: 10.1016/s0029-7844(01)01702-1.

  PMID: 11814511 BACKGROUND

• Stewart EA, Gedroyc WM, Tempany CM, Quade BJ, Inbar Y, Ehrenstein T, Shushan A, Hindley JT, Goldin RD, David M, Sklair M, Rabinovici J. Focused ultrasound treatment of uterine fibroid tumors: safety and feasibility of a noninvasive thermoablative technique. Am J Obstet Gynecol. 2003 Jul;189(1):48-54. doi: 10.1067/mob.2003.345.

  PMID: 12861137 BACKGROUND

• Hindley J, Gedroyc WM, Regan L, Stewart E, Tempany C, Hynyen K, Mcdannold N, Inbar Y, Itzchak Y, Rabinovici J, Kim HS, Geschwind JF, Hesley G, Gostout B, Ehrenstein T, Hengst S, Sklair-Levy M, Shushan A, Jolesz F. MRI guidance of focused ultrasound therapy of uterine fibroids: early results. AJR Am J Roentgenol. 2004 Dec;183(6):1713-9. doi: 10.2214/ajr.183.6.01831713.

  PMID: 15547216 BACKGROUND

• Leon-Villapalos J, Kaniorou-Larai M, Dziewulski P. Full thickness abdominal burn following magnetic resonance guided focused ultrasound therapy. Burns. 2005 Dec;31(8):1054-5. doi: 10.1016/j.burns.2005.04.019. Epub 2005 Jun 20. No abstract available.

  PMID: 15970389 BACKGROUND

• Fennessy FM, Tempany CM. MRI-guided focused ultrasound surgery of uterine leiomyomas. Acad Radiol. 2005 Sep;12(9):1158-66. doi: 10.1016/j.acra.2005.05.018.

  PMID: 16099686 BACKGROUND

• Stewart EA, Rabinovici J, Tempany CM, Inbar Y, Regan L, Gostout B, Hesley G, Kim HS, Hengst S, Gedroyc WM. Clinical outcomes of focused ultrasound surgery for the treatment of uterine fibroids. Fertil Steril. 2006 Jan;85(1):22-9. doi: 10.1016/j.fertnstert.2005.04.072.

  PMID: 16412721 BACKGROUND

• Fennessy FM, Tempany CM, McDannold NJ, So MJ, Hesley G, Gostout B, Kim HS, Holland GA, Sarti DA, Hynynen K, Jolesz FA, Stewart EA. Uterine leiomyomas: MR imaging-guided focused ultrasound surgery--results of different treatment protocols. Radiology. 2007 Jun;243(3):885-93. doi: 10.1148/radiol.2433060267. Epub 2007 Apr 19.

  PMID: 17446521 BACKGROUND

• Mara M, Fucikova Z, Maskova J, Kuzel D, Haakova L. Uterine fibroid embolization versus myomectomy in women wishing to preserve fertility: preliminary results of a randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2006 Jun 1;126(2):226-33. doi: 10.1016/j.ejogrb.2005.10.008. Epub 2005 Nov 15.

  PMID: 16293363 BACKGROUND

MeSH Terms

Conditions

Leiomyoma; Myofibroma

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Director, Clinical and Regulatory Affairs
• Organization: Philips Healthcare

sarah.baxter@philips.com

425-487-7665

Study Officials

• Herve Trillaud, Prof, MD

  Hospital St. Andre, Bordeaux, France

  PRINCIPAL INVESTIGATOR

• Lim Hyo Keun, MD

  Samsung Medical Center, Seoul, Korea

  PRINCIPAL INVESTIGATOR

• Willem Mali, Prof, MD

  University Medical Center - Utrecht, Netherlands

  PRINCIPAL INVESTIGATOR

• Joerg Barkhausen, Prof, MD

  University Hospital Schleswig-Holstein, Lübeck, Germany

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2009
• First Posted: May 12, 2009
• Study Start: April 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: December 4, 2012
• Results First Posted: November 11, 2011

Record last verified: 2012-12

Locations

KR (1); DE (1); FR (1); NL (1)