MR Guided Focused Ultrasound Surgery in the Treatment of Breast Fibroadenomas

Back to results

Primary Purpose

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

ExAblate 2000

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

NCT ID

NCT00147108

First Posted

September 2, 2005

Last Updated

September 13, 2012

Sponsor

InSightec

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

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: