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Sponsored by: |
InSightec |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00008437 |
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.
Condition | Intervention | Phase |
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Breast Cancer |
Procedure: high-intensity focused ultrasound ablation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
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 |
Study Start Date: | December 2000 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Minnesota | |
Mayo Clinic Cancer Center | |
Rochester, Minnesota, United States, 55905 | |
Canada, Quebec | |
CHUM Hopital Saint-Luc | |
Montreal, Quebec, Canada, H2X 3J4 |
Study Chair: | Robert W. Newman | InSightec |
Study ID Numbers: | CDR0000068417, TXS-G990184, DFCI-99029, MDA-ID-99137, TXS-1999-P-009925/10, NCI-V00-1643 |
Study First Received: | January 6, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00008437 |
Health Authority: | United States: Federal Government |
stage I breast cancer stage II breast cancer stage IIIA breast cancer |
Skin Diseases Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site |