Microwave Ablation of Breast Tumors
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Locations
- 1
- Primary Endpoint
- Amount of tissue destruction with MedWaves Microwave Ablation/ Coagulation System.
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- Female
- Accepts 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
Outcomes
Primary Outcomes
Amount of tissue destruction with MedWaves Microwave Ablation/ Coagulation System.
Time Frame: 30 days
Measure tissue destruction with the MedWaves Microwave Ablation/ Coagulation System through pathological review of destruction.
Secondary Outcomes
- Amount of toxicity of microwave ablation in patients.(30 Days)
- Provide the differences between percutaneous and open Microwave Ablation(30 Days)