Microwave Ablation of Breast Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Study Completion Date

2012-12-31

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.

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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.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Microwave Ablation/ Coagulation Arm

These patients will receive microwave ablation using MedWaves Microwave Ablation/ Coagulation System.

Microwave Ablation/ Coagulation Arm

Intervention Type DEVICE

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.

Interventions

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Microwave Ablation/ Coagulation Arm

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.

Intervention Type DEVICE

Other Intervention Names

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Medwaves Microwave Ablation/ Coagulation System

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