- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00008437
MRI-Guided Ultrasound Energy in Treating Patients With Stage I, Stage II, or Stage IIIA Breast Cancer
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Quebec
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Montreal, Quebec, Canada, H2X 3J4
- CHUM Hopital Saint-Luc
-
-
-
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic Cancer Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Robert W. Newman, InSightec
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000068417
- TXS-G990184
- DFCI-99029
- MDA-ID-99137
- TXS-1999-P-009925/10
- NCI-V00-1643
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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