MR Guided Focused Ultrasound Surgery in the Treatment of Breast Fibroadenomas

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
InSightec
ClinicalTrials.gov Identifier:
NCT00147108
First received: September 2, 2005
Last updated: September 13, 2012
Last verified: September 2012
  Purpose

The primary objective of this pivotal study is to evaluate the safety and efficacy of FUS treatment of breast fibroadenomas. Our hypothesis is that FUS lesion ablation of a fibroadenoma will have the following results: a. lead to a decrease in lesion cross-sectional area of > 50% on palpation, and >65% in lesion volume as measured by MRI (both calculations assume an elliptical shape of the lesion in all 3 dimensions). b. this decrease in size, along with the softening of the treated volume will result in satisfactory clinical results in greater than 50 % of the patients.


Condition Intervention Phase
Breast Fibroadenoma
Device: ExAblate 2000
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 3 Study of MR Guided Focused Ultrasound Surgery in the Treatment of Breast Fibroadenomas

Resource links provided by NLM:


Further study details as provided by InSightec:

Primary Outcome Measures:
  • treatment/ablation of breast fibroadenoma

Enrollment: 102
Study Start Date: January 2003
Study Completion Date: October 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
Detailed Description:

Many patients are now diagnosed with breast fibroadenomas. These are generally detected during breast self-exams, or annual physicals as a smooth, rubbery, oval/elliptical lump in the breast. These patients then go on to receive mammograms, sonograms and usually a core biopsy for the differential diagnosis of benign disease (fibroadenoma) vs breast cancer. Although fibroadenomas are benign, they can be of great concern to the patient because of their ability to mask the presence of other lumps in the breast, they can be painful, cause a physical deformity of the breast or have other symptoms. The current treatment is surgical excision. Surgical removal is invasive and may be cosmetically undesirable to some patients. It would be advantageous to develop a non-invasive ablative method for treatment of this disease. Measures of the clinical success of patients who elect surgical removal of fibroadenomas are generally subjective, and evaluated primarily by the patient (lack of palpable lesion, pain free, and an acceptable cosmetic result). A non-randomized study is proposed to allow for a more practical approach in subject recruitment. Analysis on safety and efficacy will be performed through the use of MRI evaluation and physical exams.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Gender: Females only
  • Histologic confirmation of breast fibroadenoma by large core (needle gauge range 11-14 ) biopsy.
  • Single tumor per breast quadrant
  • Tumor clearly visible on non-contrast MRI
  • Age > 18 years 3.2.6 Signed informed consent
  • Tumor 5 mm or larger as measured on pre-treatment MR.

Exclusion Criteria:

  • Gender: male
  • Focal breast lesion on MRI over 3.5 cm as evaluated by MRI
  • Distance from the edge of the breast fibroadenoma to the skin less than 0.5-cm or ribs less than 1 cm.
  • Microcalcifications within the lesion
  • Known intolerance to the MRI contrast agent (Gadolinium or Magnevist) 3.3.6 Patients on dialysis.
  • Hemolytic anemia (hematocrit<30)
  • Patients with unstable cardiac status including: Unstable angina pectoris on medication Patients with documented myocardial infarction within six months of protocol entry Congestive heart failure requiring medication (other than diuretic) Patients on anti-arrhythmic drugs Severe hypertension (diastolic BP > 100 on medication)
  • Patients with cardiac pacemakers
  • ASA Score>2
  • Severe cerebrovascular disease (multiple CVA or CVA within 6 months) 3.3.12 Individuals who are not able or willing to tolerate the required prolonged stationary prone position during treatment (approximately 3 hrs.) 3.3.13 Patients with breast implants
  • Large patients who cannot fit in the magnet (weight>250 pounds), and patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices
  • Patients on anti-coagulation therapy, or those with an underlying bleeding disorder.
  • Patient has a prior history of breast cancer
  • Patient has a prior history of laser or radiation therapy to the target breast
  • Patient has a prior history of chemo therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00147108

Locations
United States, Florida
University MRI
Boca Raton, Florida, United States, 33431
United States, Massachusetts
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
United States, New Jersey
Virtua
Voorhees, New Jersey, United States, 08043
United States, New York
Cornell Vascular
New York, New York, United States, 10022
Japan
Breastopia Namba Hospital
Miyazaki-ken, Japan, 880-0052
Sponsors and Collaborators
InSightec
Investigators
Principal Investigator: Clare Tempany, M.D. Brigham and Women's Hospital
Principal Investigator: Robert Min, M.D. Cornell Vascular
Principal Investigator: Fred Steinberg, M.D. University MRI
Principal Investigator: Mark DeLaurentis, M.D. Virtua
Principal Investigator: Hidemi Furusawa, M.D. Breastopia Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: InSightec
ClinicalTrials.gov Identifier: NCT00147108     History of Changes
Other Study ID Numbers: BF002
Study First Received: September 2, 2005
Last Updated: September 13, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by InSightec:
Breast Cancer

Additional relevant MeSH terms:
Fibroadenoma
Neoplasms, Fibroepithelial
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on August 25, 2014