Breast Cancer
Conditions
Keywords
Breast Cancer, Tumors
Brief summary
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
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.
Interventions
DEVICEMicrowave 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.
Sponsors
St. Joseph Hospital of Orange
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amount of tissue destruction with MedWaves Microwave Ablation/ Coagulation System. | 30 days | Measure tissue destruction with the MedWaves Microwave Ablation/ Coagulation System through pathological review of destruction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Provide the differences between percutaneous and open Microwave Ablation | 30 Days | Evaluate differences between percutaneous and open Microwave Ablation through pathological review and patient follow-up. |
| Amount of toxicity of microwave ablation in patients. | 30 Days | Measure toxicity of Microwave Ablation through patient follow-up and assessment. |
Countries
United States
Outcome results
None listed