Microwave Ablation of Breast Tumors

Study Overview
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Brief Summary
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The purpose of this protocol is to pathologically evaluate the amount of destruction of cancer cells by Microwave Ablation (MWA) in primary breast tumors.

Detailed Description
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Minimally invasive surgical alternatives are becoming more attractive for the treatment of malignancy due to improvements in technology, reduced costs and reduced morbidity. The main objective of this protocol is to determine the extent of ablation based on time and power parameters of the MedWaves in breast cancers. This would be accomplished in patients diagnosed with breast cancer who are already scheduled for breast cancer surgery. Prior to the surgical removal of the cancer, the microwave antenna would be inserted into the tumor under ultrasound guidance (either percutaneously or open). The tumor would be ablated, and then surgically resected in a standard, curative fashion.

Official Title
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Microwave Ablation of Breast Tumors

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: Microwave Ablation/ Coagulation Arm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: a diagnosis of primary breast tumor for which a surgical resection (excisional, biopsy, segmentectomy or mastectomy) is planned. Tumor is palpable or visible on ultrasound or both All participants need to be fully able to give informed consent Exclusion Criteria: Gender: male Mental or legal incompetence Impaired decision-making capacity Pregnant women may not participate Implanted Pacemaker

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Microwave Ablation/ Coagulation Arm<br>These patients will receive microwave ablation using MedWaves Microwave Ablation/ Coagulation System. | Device: Microwave Ablation/ Coagulation Arm<br>* An 11-gauge microwave probe from MedWaves, Inc., will be placed in the tumor. An ablation lesion will then be generated at the appropriate power (10-35 watts) to maintain up to 130C degrees at the MW applicator tip thermocouple for 10 minutes duration. Palpation and/or ultrasound may be used to place the MWA needle and monitor the progress of the microwave ablation.<br>* Other names: Medwaves Microwave Ablation/ Coagulation System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of tissue destruction with MedWaves Microwave Ablation/ Coagulation System. | Measure tissue destruction with the MedWaves Microwave Ablation/ Coagulation System through pathological review of destruction. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Provide the differences between percutaneous and open Microwave Ablation | Evaluate differences between percutaneous and open Microwave Ablation through pathological review and patient follow-up. | 30 Days | 
| Amount of toxicity of microwave ablation in patients. | Measure toxicity of Microwave Ablation through patient follow-up and assessment. | 30 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Tumors