Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	Other	TXS-G990184 DFCI-99029, MDA-ID-99137, TXS-1999-P-009925/10, NCI-V00-1643, NCT00008437

Objectives

1. Determine the incidence and severity of adverse events during and after MRI-guided focused ultrasound ablation in women with stage I-IIIA breast cancer.
2. 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.
3. 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.
4. Determine patient acceptance of this procedure, in terms of positioning, pain, safety, and follow-up cosmesis.

Entry 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

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

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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

InSightec, Limited

Robert Newman, Protocol chair		Ph: 214-630-2000

Registry Information
Official Title		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
Trial Start Date		2000-12-12
Registered in ClinicalTrials.gov		NCT00008437
Date Submitted to PDQ		2000-12-12
Information Last Verified		2005-04-06

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