Microwave Ablation of Breast Tumors

Breast Cancer Clinical Trial

Official title:

Microwave Ablation of Breast Tumors

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04828044
• Other study ID #: 12-028 MWA - Breast Tumors
• Status: Withdrawn
• Start date: September 2012
• Est. completion date: December 2012

Study information

• Verified date: March 2021
• Source: St. Joseph Hospital of Orange
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	St. Joseph Hospital of Orange	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
St. Joseph Hospital of Orange

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Amount of toxicity of microwave ablation in patients.	Measure toxicity of Microwave Ablation through patient follow-up and assessment.	30 Days