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Uterine FibroidsPhase 2/3SOFIANCT01504308

Sonalleve Fibroid Ablation Pivotal Clinical Trial for MR-HIFU of Uterine Fibroids

A Phase 2/3 study testing MR-HIFU treatment in people with Uterine Fibroids, run by Philips Healthcare at 9 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this clinical study is to determine whether treatment with the Philips Sonalleve Magnetic Resonance-guided High Intensity Focused Ultrasound (MR-HIFU) system is effective in the treatment symptomatic uterine leiomyomas (uterine fibroids). Read more about this study

Who is it for?
Ages 18 to 50 years, women only
Conditions the study is for
Uterine Fibroids
What is being tested?
MR-HIFU treatment
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
49 participants
Where
9 sitesin 3 countries
Study dates
May 2012to Mar 2016
Phase
Phase 2/3
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, age between 18 and 50 years
  • Ethnicity has a match with the intended profile for the site
  • Weight < 140kg or 310lbs
  • Pre- or peri-menopausal as indicated by clinical evaluation or Follicle Stimulating Hormone (FSH) level < 40 IU/L
  • Willing and able to attend all study visits
  • Willing and able to complete Menstrual Blood Loss (MBL) assessment with Alkaline Hematin (AH) method
Show all 17Show fewer
  • Willing and able to use reliable contraception methods
  • Uterine size < 24 weeks
  • Cervical cell assessment by Pap smear: Normal, Low Grade Squamous Intraepithelial Lesion (SIL), Low risk Human Papillomavirus (HPV) or Atypical Squamous Cells of Uncertain Significance (ASCUS) subtypes of cervical tissue
  • MR-HIFU device accessibility to fibroids such that at least 50% of the total fibroid volume can be treated.
  • Fibroids selected for treatment meeting the following criteria (further extrapolated in the protocol):
  • Total planned ablation volume of all fibroids should not exceed 250 ml and
  • No more than 5 fibroids should be planned for ablation and
  • Dominant fibroid (diameter) is greater than or equal to 3 cm and
  • Completely non-enhancing fibroids should not be treated as the identification of treated volume becomes ambiguous
  • Patient's self-assessment indicates that she has had episodes of heavy menstrual bleeding in the past 6 months.
  • Menstrual Blood Loss (MBL) ≥150 ml and ≤ 500 ml

Who cannot join

  • Other Pelvic Disease (Other mass, endometriosis, ovarian tumor, acute pelvic disease, significant adenomyosis)
  • Desire for future pregnancy
  • Significant systemic disease even if controlled
  • Positive pregnancy test
  • Hematocrit < 25%
  • Extensive scarring along anterior lower abdominal wall (>50% of area)
Show all 18Show fewer
  • Surgical clips in the potential path of the HIFU beam
  • MRI contraindicated
  • MRI contrast agent contraindicated (including renal insufficiency)
  • Calcifications around or throughout uterine tissues that may affect treatment
  • Communication barrier
  • Highly perfused or brighter than myometrium in T2-weighted MRI (according to the T2 contrast obtained using the Philips MR-HIFU MR protocol) fibroids
  • Fibroids not quantifiable on MRI (e.g. multi-fibroid cases where volume measurements are not feasible)
  • Menses lasting > 7 days or intermenstrual bleeding (patient can be included if there is endometrial biopsy within 6 months to exclude malignancy)
  • Patient is currently on hormonal medication for fibroids or has a hormonal medication history as described below:
  • 1-month Lupron dose or equivalent: less than 1 month prior to MBL measurement or
  • 3-month Lupron dose or equivalent: less than 3 months prior to MBL measurement or
  • Depo Provera or equivalent: less than 6 months prior to MBL measurement

Trial locations and contacts

9 sites in 3 countries.

9 sites in 3 countries

United States7 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • University of Chicago

    Chicago, Illinois, 60637

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75235

  • St. Luke's Episcopal Hospital

    Houston, Texas, 77030

  • Vanderbilt Medical Center

    Nashville, Tennessee, 37232

  • Oregon Science and Health University

    Portland, Oregon, 97239

  • Montefiore Medical Center

    The Bronx, New York, 10467

Other trials in United States

Canada1 site

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario

Other trials in Canada

South Korea1 site

  • Samsung Medical Center

    Seoul

Other trials in South Korea

About this study

Official title: Philips Pivotal Clinical Trial for MRI-guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids

The purpose of this clinical study is to determine whether treatment with the Philips Sonalleve Magnetic Resonance-guided High Intensity Focused Ultrasound (MR-HIFU) system is effective in the treatment symptomatic uterine leiomyomas (uterine fibroids).

Read the detailed description

Uterine Fibroids are the most common benign tumors in pre- and peri-menopausal women. Fibroids occur in 20-50% of women over 30 years of age, and with increasing size can produce pain, menorrhagia, pressure, bloating and urinary and bowel compression symptoms. Fibroids may also cause infertility. Symptomatic fibroids impact health and well-being of the female including lost work hours and reduced quality of life.

Current medical treatments include invasive removal of the fibroid (hysterectomy, myomectomy), drug therapy, or treatments causing necrosis of the fibroid tissue such as ablation (freezing or heating) or embolization. It has been estimated that 600,000 hysterectomies are performed per year in the United States and more than half of the conducted hysterectomies are due to fibroids. For the relief of symptoms, women wishing to preserve the uterus may choose between invasive procedures of myomectomy, Uterine Artery Embolization (UAE), ablation or cryotherapy. The surgically invasive procedures require anesthesia, hospital stays, and long recovery periods. However, High Intensity Focused Ultrasound (HIFU) shows promising results in relieving fibroid symptoms.

This study will confirm the safety and clinical effectiveness of Philips Sonalleve MR-HIFU Fibroid Therapy system for ablating symptomatic fibroids.

Being tested
MR-HIFU treatment, Sham treatment
Keywords
uterine fibroids, uterine leiomyomas, magnetic resonance imaging, focused ultrasound
Medical subject headings
Leiomyoma, Myofibroma

What participants receive

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

  • MR-HIFU treatmentDevice

    Also called Philips Sonalleve MR-HIFU Uterine Fibroid Therapy

    A treatment session with the Philips Sonalleve MR-HIFU device for thermal ablation of uterine fibroids with high-intensity focused ultrasound.

  • Sham treatmentDevice

    Also called pretend treatment with Philips Sonalleve MR-HIFU

    A pretend treatment session with the Philips Sonalleve MR-HIFU system in which no therapeutic ultrasound doses are delivered.

Study groups in NCT01504308
Study groupRoleWhat they receive
MR-HIFU treatmentExperimentalPatients receiving MR-HIFU treatment
Receives: Device: MR-HIFU treatment
Sham TreatmentSham comparatorPatients receiving sham treatment
Receives: Device: Sham treatment

What is being measured

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

  1. Alternative Interventional Treatment (AIT)

    AIT is scored dichotomously as follows:

    0 = Failure. Failure occurs if an AIT for fibroid related symptoms is administered within 12 months of study treatment.

    1 = Success. Success occurs if no AIT is administered for fibroid related symptoms within 12 months of study treatment.

    An AIT is defined as being one of the following: hysterectomy, myomectomy, uterine artery embolization, endometrial ablation and resection, or another MR-HIFU treatment (with the exception of a 're-treatment' as defined in the protocol, e.g. because of temporarily inaccessible fibroids).

    Measured: 12 months after HIFU treatment

  2. Menstrual Blood Loss (MBL)

    Menstrual Blood Loss (MBL) scored dichotomously as follows:

    0 = Failure. Failure occurs if the change from baseline in MBL measurement is < 50 % as measured with alkaline hematin test (AHT) method.

    1 = Success. Success occurs if the change from baseline in MBL measurement is >= 50 %, or if the MBL is < 80 ml as measured with the AHT method.

    Measured: at baseline and at 12 months following treatment

Secondary outcomes (2)

  1. Return to Activity

    Length for Return to Activity after HIFU treatment measured dichotomously:

    0 = Failure. If subject takes longer than 72 hours to return to work or normal activity.

    1 = Success. If subject returns to work or normal activity within 72 hours inclusive.

    Measured: 72 hours

  2. Symptom Severity Score (SSS)

    Symptom Severity Score (SSS) of Uterine Fibroid Symptom and Quality of Life questionnaire (UFS-QoL), assessed dichotomously at 12 months:

    0 = Failure. Reduction of less than 10 points on SSS.

    1 = Success. Reduction of at least 10 points on SSS.

    Measured: at baseline and at 12 months following treatment

Timeline

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

  1. First posted5 Jan 2012 (estimated)
  2. Study startMay 2012
  3. Primary completionMar 2016
  4. Study completionMar 2016

Why it stopped: It was not possible to enroll patients into the study in a realistic timeframe.

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01504308
Sponsor's protocol ID
994045
Other IDs
G110008
Acronym
SOFIA
Status last verified
Apr 2017
First submitted
3 Jan 2012
Last updated
5 Apr 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Voogt MJ, Trillaud H, Kim YS, Mali WP, Barkhausen J, Bartels LW, Deckers R, Frulio N, Rhim H, Lim HK, Eckey T, Nieminen HJ, Mougenot C, Keserci B, Soini J, Vaara T, Kohler MO, Sokka S, van den Bosch MA. Volumetric feedback ablation of uterine fibroids using magnetic resonance-guided high intensity focused ultrasound therapy. Eur Radiol. 2012 Feb;22(2):411-7. doi: 10.1007/s00330-011-2262-8. Epub 2011 Sep 8.

    PubMed 21901565

  • 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.

    PubMed 11814511

  • 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.

    PubMed 12861137

  • 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.

    PubMed 15547216

  • 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.

    PubMed 15970389

  • 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.

    PubMed 16099686

  • 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.

    PubMed 16412721

  • 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.

    PubMed 17446521

  • 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.

    PubMed 16293363

  • 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

  • Taran FA, Tempany CM, Regan L, Inbar Y, Revel A, Stewart EA; MRgFUS Group. Magnetic resonance-guided focused ultrasound (MRgFUS) compared with abdominal hysterectomy for treatment of uterine leiomyomas. Ultrasound Obstet Gynecol. 2009 Nov;34(5):572-8. doi: 10.1002/uog.7435.

    PubMed 19852046

  • Funaki K, Fukunishi H, Sawada K. Clinical outcomes of magnetic resonance-guided focused ultrasound surgery for uterine myomas: 24-month follow-up. Ultrasound Obstet Gynecol. 2009 Nov;34(5):584-9. doi: 10.1002/uog.7455.

    PubMed 19852041

  • Okada A, Morita Y, Fukunishi H, Takeichi K, Murakami T. Non-invasive magnetic resonance-guided focused ultrasound treatment of uterine fibroids in a large Japanese population: impact of the learning curve on patient outcome. Ultrasound Obstet Gynecol. 2009 Nov;34(5):579-83. doi: 10.1002/uog.7454.

    PubMed 19852042

  • Kim YS, Lim HK, Kim JH, Rhim H, Park BK, Keserci B, Kohler MO, Bae DS, Kim BG, Lee JW, Kim TJ, Sokka S, Lee JH. Dynamic contrast-enhanced magnetic resonance imaging predicts immediate therapeutic response of magnetic resonance-guided high-intensity focused ultrasound ablation of symptomatic uterine fibroids. Invest Radiol. 2011 Oct;46(10):639-47. doi: 10.1097/RLI.0b013e318220785c.

    PubMed 21654495

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing MR-HIFU treatment in people with Uterine Fibroids, run by Philips Healthcare at 9 sites in 3 countries.

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 17 inclusion and 18 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: stopped early, as of the sponsor's last update on 5 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States, Canada, South Korea. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 stopped early (reason given: It was not possible to enroll patients into the study in a realistic timeframe.). Results are not available in the source record.

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?

Alternative Interventional Treatment (AIT) (time frame: 12 months after HIFU treatment). The study lists 2 primary outcomes in all. 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 NCT01504308, which also lists 14 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 5 Apr 2017.

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