NCT00373152

MRI in Predicting Tumor Reponse After Radiofrequency Ablation in Women With Invasive Breast Cancer

Breast MRI Assessment of Tumor Viability After Radiofrequency Ablation (RFA)

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	Lumpectomy	Standard lumpectomy or mastectomy will be performed 1 to 21 days after the post-RFA MRI.
PROCEDURE	dynamic contrast-enhanced magnetic resonance imaging	Dynamic-contrast enhanced breast images will be visualized with parametric image maps to assist in identifying regions with residual cancer.
PROCEDURE	radiofrequency ablation	RFA is accomplished by placing a multi-array needle within a tumor. The tines of the needle are advanced and opened like an inverted umbrella. High frequency, alternating current moves from the tip of an electrode into the surrounding tissue. Oscillating ions generate frictional heat within the tumor. Cell death occurs at sustained temperatures above 45-50 degrees C. The multi-array configuration creates an egg-shaped ablation zone up to 5 cm in diameter.
RADIATION	gadopentetate dimeglumine	Injected at baseline MRI and post radiofrequency ablation MRI.

Timeline

• Start date: 2005-03-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2006-09-07
• Last updated: 2017-12-05