Microwave Ablation of Breast Tumors

March 30, 2021 updated by: St. Joseph Hospital of Orange
The purpose of this protocol is to pathologically evaluate the amount of destruction of cancer cells by Microwave Ablation (MWA) in primary breast tumors.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Orange, California, United States, 92868
        • St. Joseph Hospital of Orange

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients with a diagnosis of primary breast tumor for which a surgical resection (excisional, biopsy, segmentectomy or mastectomy) is planned.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Microwave Ablation/ Coagulation Arm
These patients will receive microwave ablation using MedWaves Microwave Ablation/ Coagulation System.
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.
Other Names:
  • Medwaves Microwave Ablation/ Coagulation System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Provide the differences between percutaneous and open Microwave Ablation
Time Frame: 30 Days
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.
Time Frame: 30 Days
Measure toxicity of Microwave Ablation through patient follow-up and assessment.
30 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Joseph Hospital of Orange

Investigators

  • Principal Investigator: Lawrence Wagman, M.D., St. Joseph Hospital of Orange

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

September 12, 2012

First Submitted That Met QC Criteria

March 30, 2021

First Posted (Actual)

April 1, 2021

Study Record Updates

Last Update Posted (Actual)

April 1, 2021

Last Update Submitted That Met QC Criteria

March 30, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-028 MWA - Breast Tumors

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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