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

Study Overview
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Brief Summary
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RATIONALE: Imaging procedures, such as MRI, may allow the doctor to better detect the tumor. Highly focused ultrasound energy may be able to kill tumor cells by heating the breast tumor cells without affecting the surrounding tissue. PURPOSE: Phase II trial to study the effectiveness of MRI-guided ultrasound energy in treating women who have stage I, stage II, or stage IIIA breast cancer.

Detailed Description
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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.

Official Title
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Pilot Study of MR-Guided Focused Ultrasound for Tissue Coagulation in Women With Breast Cancer: MR Imaging and Histopathic Correlation, An Assessment or Target Accuracy and Patient Acceptance

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: high-intensity focused ultrasound ablation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: high-intensity focused ultrasound ablation|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I breast cancer, stage II breast cancer, stage IIIA breast cancer