search
Back to results

MR Guided Focused Ultrasound Surgery in the Treatment of Breast Fibroadenomas

Primary Purpose

Breast Fibroadenoma

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ExAblate 2000
Sponsored by
InSightec
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Fibroadenoma focused on measuring Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University MRI
  • Brigham & Women's Hospital
  • Virtua
  • Cornell Vascular
  • Breastopia Namba Hospital

Outcomes

Primary Outcome Measures

treatment/ablation of breast fibroadenoma

Secondary Outcome Measures

Full Information

First Posted
September 2, 2005
Last Updated
September 13, 2012
Sponsor
InSightec
search

1. Study Identification

Unique Protocol Identification Number
NCT00147108
Brief Title
MR Guided Focused Ultrasound Surgery in the Treatment of Breast Fibroadenomas
Official Title
Phase 3 Study of MR Guided Focused Ultrasound Surgery in the Treatment of Breast Fibroadenomas
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Terminated
Study Start Date
January 2003 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
October 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
InSightec

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Fibroadenoma
Keywords
Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
ExAblate 2000
Primary Outcome Measure Information:
Title
treatment/ablation of breast fibroadenoma

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clare Tempany, M.D.
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Min, M.D.
Organizational Affiliation
Cornell Vascular
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fred Steinberg, M.D.
Organizational Affiliation
University MRI
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark DeLaurentis, M.D.
Organizational Affiliation
Virtua
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hidemi Furusawa, M.D.
Organizational Affiliation
Breastopia Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University MRI
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33431
Country
United States
Facility Name
Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Virtua
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Cornell Vascular
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
Breastopia Namba Hospital
City
Miyazaki-ken
ZIP/Postal Code
880-0052
Country
Japan

12. IPD Sharing Statement

Links:
URL
http://www.insightec.com
Description
Sponsor web page

Learn more about this trial

MR Guided Focused Ultrasound Surgery in the Treatment of Breast Fibroadenomas

We'll reach out to this number within 24 hrs