MRI in Predicting Tumor Reponse After Radiofrequency Ablation in Women With Invasive Breast Cancer
|ClinicalTrials.gov Identifier: NCT00373152|
Recruitment Status : Withdrawn (No patient accrual)
First Posted : September 7, 2006
Last Update Posted : December 5, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Procedure: Lumpectomy Procedure: dynamic contrast-enhanced magnetic resonance imaging Procedure: radiofrequency ablation Radiation: gadopentetate dimeglumine||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Breast MRI Assessment of Tumor Viability After Radiofrequency Ablation (RFA)|
|Study Start Date :||March 2005|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||June 2010|
|Experimental: RadioFrequency Ablation for Breast Cancer||
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.
Other Name: MRIProcedure: 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.
- Complete Tumor NecrosisEfficacy of radiofrequency ablation (RFA) in inducing complete tumor necrosis as measured by immunohistochemical and biomarker studies.
- Sensitivity and specificity of delayed dynamic contrast-enhanced MRI (DCE-MRI) in detecting residual cancer after RFA as measured by the Hylton method
- Cosmetic Outcome [ Time Frame: after RFA but before definitive surgery ]as rated by EORTC QLQ-C30. The EORTC QLQ-C30 is a questionnaire developed to assess the quality of life of cancer patients. The rating system includes evaluation of breast size and shape, skin tone, nipple shape and location, appearance of the surgical scar, and overall cosmetic results. With the exception of evaluation of the surgical scar, all ratings are based on a comparison of the treated breast with the untreated breast. Patients will also rate the cosmetic outcome as excellent-good-fair-poor.
- Toxicity or complications of RFA [ Time Frame: before definitive surgery ]
as assessed by CTCAE v3.0 (Common Toxicity Criteria for Adverse Events, version 3.0).
Any complications of RFA will be determined and documented before definitive surgery. Anticipated complications may include bleeding, pain, infection, and skin and chest muscle burns.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00373152
|Study Chair:||Todd M. Tuttle, MD||Masonic Cancer Center, University of Minnesota|