Phase 3 Study of MR Guided Focused Ultrasound Surgery in the Treatment of Breast Fibroadenomas
18 Years
N/A
Female
Breast Fibroadenoma
Trial Information
Phase 3 Study of MR Guided Focused Ultrasound Surgery in the Treatment of Breast Fibroadenomas
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
treatment/ablation of breast fibroadenoma
Principal Investigator
Clare Tempany, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Brigham and Women's Hospital
Authority:
United States: Food and Drug Administration
Study ID:
BF002
NCT ID:
NCT00147108
Start Date:
January 2003
Completion Date:
October 2005
Related Keywords:
- Breast Fibroadenoma
- Breast Cancer
- Fibroadenoma
Name | Location |
|---|---|
| Brigham & Women's Hospital | Boston, Massachusetts 02115 |
| Cornell Vascular | New York, New York 10022 |
| University MRI | Boca Raton, Florida 33431 |
| Virtua | Voorhees, New Jersey 08043 |
