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
- 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.
Primary Purpose: Treatment
Robert W. Newman
United States: Food and Drug Administration
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|