NCT00008437CompletedPhase 2
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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- InSightec
- Locations
- 4
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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:
- •18 and over
- •Menopausal status:
- •Not specified
- •Performance status:
- •Karnofsky 80-100%
- •Life expectancy:
- •At least 5 years
- •Hematopoietic:
- •No hemolytic anemia (hematocrit less than 30%)
- •Not specified
- •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
- •No chronic obstructive pulmonary disease
- •No other lung disease
- •No sleep apnea or airway problems
- •No severe asthma
- •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
- +11 more not shown
Exclusion Criteria
- Not provided
Investigators
Study Sites (4)
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