MRI-Guided Ultrasound Energy in Treating Patients With Stage I, Stage II, or Stage IIIA Breast Cancer

OBJECTIVES:

• Determine the incidence and severity of adverse events during and after MRI-guided focused ultrasound ablation in women with stage I-IIIA breast cancer.
• Determine the ability to accurately and thoroughly coagulate a target volume of breast carcinoma, in terms of real-time target volume temperature profile, follow-up MRI, and histology, using this procedure.
• Compare the appearance of gross and microscopic histopathologic tissue post coagulation with the pre- and post-coagulation magnetic resonance appearance of the targeted volume and measure any residual cancer cells in patients after this procedure.
• Determine patient acceptance of this procedure, in terms of positioning, pain, safety, and follow-up cosmesis.

OUTLINE: This is a pilot study.

Patients undergo MRI-guided focused ultrasound (MRgFUS) ablation of the breast lesion using a series of pulses. Within 72 hours after MRgFUS procedure, patients undergo gadolinium-enhanced MRI to evaluate ablation borders. Within 7-10 days after MRgFUS procedure, patients undergo an ultrasound exam. Guide wires may be placed to assist in pre-surgical lesion localization. Within 10-21 days after MRgFUS procedure, patients undergo segmental resection or mastectomy.

Patients are followed at 5-10 days post-surgery.

PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

• Histologically confirmed invasive breast cancer (T1, N0-2, M0)
• Single focal lesion no greater than 3.5 cm in diameter by MRI
• No lesions difficult to target, defined as less than 1 cm from skin, nipple, or rib cage
• No microcalcifications as sole sign of disease
• No extensive intraductal components on core biopsy, defined as intraductal carcinoma comprising 25% or more of the invasive breast cancer AND intraductal carcinoma in surrounding normal tissue
• No breast implants
• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Sex:

• Female

Menopausal status:

• Not specified

Performance status:

• Karnofsky 80-100%

Life expectancy:

• At least 5 years

Hematopoietic:

• No hemolytic anemia (hematocrit less than 30%)

Hepatic:

• Not specified

Renal:

• Not specified

Cardiovascular:

• No heart disease
• No unstable angina pectoris requiring medication
• No myocardial infarction within the past 6 months
• No congestive heart failure requiring medication
• No diastolic blood pressure greater than 100 mm Hg while receiving medication to treat hypertension
• No cerebrovascular accident (CVA) within the past 6 months
• No multiple CVAs
• No cardiac pacemakers

Pulmonary:

• No chronic obstructive pulmonary disease
• No other lung disease
• No sleep apnea or airway problems
• No severe asthma

Other:

• Not pregnant or nursing
• Fertile patients must use effective contraception
• No contraindications to MRI (e.g., implanted medical devices)
• Must be able to lie prone and still for up to 150 minutes
• Weight no greater than 250 pounds
• No severe arthritis
• No severe claustrophobia
• No grand mal seizures
• No insulin-dependent diabetes mellitus
• No prior reaction to gadolinium-based contrast agent
• Able to communicate sensations during procedure

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• At least 3 months since prior chemotherapy

Endocrine therapy:

• Concurrent hormone replacement therapy allowed
• Concurrent tamoxifen allowed
• No concurrent steroids

Radiotherapy:

• No prior external radiotherapy or laser therapy to ipsilateral breast

Surgery:

• See Disease Characteristics

Other:

• No concurrent anti-arrhythmic drugs
• No concurrent immunosuppressive medication
• No concurrent anticoagulation therapy
• No concurrent dialysis