Breast MRI Assessment of Tumor Viability After Radiofrequency Ablation (RFA)
- Determine if radiofrequency ablation (RFA) can induce complete tumor necrosis in women
with invasive breast cancer.
- 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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Complete Tumor Necrosis
Efficacy of radiofrequency ablation (RFA) in inducing complete tumor necrosis as measured by immunohistochemical and biomarker studies.
Todd M. Tuttle, MD
Masonic Cancer Center, University of Minnesota
United States: Food and Drug Administration