Microwave Ablation of Breast Tumors

NCT04828044 | Withdrawn

• 1 other identifier: 12-028 MWA - Breast Tumors
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast Cancer; Tumors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Provide the differences between percutaneous and open Microwave Ablation

  30 Days

• Amount of toxicity of microwave ablation in patients.

  30 Days

Study Arms (1)

Microwave Ablation/ Coagulation Arm

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

Device: Microwave Ablation/ Coagulation Arm

Interventions

Microwave Ablation/ Coagulation Arm 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.

Also known as: Medwaves Microwave Ablation/ Coagulation System

Microwave Ablation/ Coagulation Arm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Gender: male
• Mental or legal incompetence
• Impaired decision-making capacity
• Pregnant women may not participate
• Implanted Pacemaker

Sponsors & Collaborators

• St. Joseph Hospital of Orange: lead

Study Sites (1)

St. Joseph Hospital of Orange

Orange, California, 92868, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tissue specimens will be evaluated and stored as standard surgical pathology specimens by the St. Joseph Hospital Department of Pathology. Additional tissue needed for tumor marker studies will be obtained prior to MWA.

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Lawrence Wagman, M.D.

  St. Joseph Hospital of Orange

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2012
• First Posted: April 1, 2021
• Study Start: September 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 1, 2021

Record last verified: 2021-03

Locations

US (1)