Breast Cancer Clinical Trial
Official title:
Breast MRI Assessment of Tumor Viability After Radiofrequency Ablation (RFA)
RATIONALE: Radiofrequency ablation uses a high-frequency, electric current to kill tumor
cells. Diagnostic procedures, such as magnetic resonance imaging (MRI), may help in learning
how well radiofrequency ablation works to kill breast cancer cells and help doctors predict
whether breast cancer cells remain after treatment.
PURPOSE: This phase II trial is studying how well MRI works in predicting tumor response
after radiofrequency ablation in women with invasive breast cancer.
OBJECTIVES:
Primary
- Determine if radiofrequency ablation (RFA) can induce complete tumor necrosis in women
with invasive breast cancer.
Secondary
- Determine whether breast MRI can accurately predict residual cancer and tumor necrosis
in patients treated with RFA.
- Determine the toxicity of RFA in these patients.
- Determine the cosmetic outcome after RFA in these patients.
OUTLINE: This is a prospective, nonrandomized study.
Patients undergo dynamic contrast-enhanced MRI (DCE-MRI) using gadopentetate dimeglumine.
Within the next few days, patients undergo radiofrequency ablation (RFA) over approximately
20-30 minutes. Patients then undergo a second DCE-MRI 3 to 21 days after RFA, followed by
definitive surgery (standard mastectomy or lumpectomy).
Pathologic confirmation of the post-ablation DCE-MRI findings is performed within 1 to 21
days after the second MRI. Tumor cell viability and proliferative activity are assessed by
immunohistochemical and biomarker analysis.
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