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

Trial Information

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

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.

Inclusion Criteria

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Robert W. Newman

Investigator Role:

Study Chair

Investigator Affiliation:

InSightec

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000068417

NCT ID:

NCT00008437

Start Date:

December 2000

Completion Date: