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The purpose of this protocol is to pathologically evaluate the amount of destruction of cancer cells by Microwave Ablation (MWA) in primary breast tumors.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Microwave Ablation/ Coagulation Arm | These patients will receive microwave ablation using MedWaves Microwave Ablation/ Coagulation System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Amount of toxicity of microwave ablation in patients. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with a diagnosis of primary breast tumor for which a surgical resection (excisional, biopsy, segmentectomy or mastectomy) is planned.
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| Name | Affiliation | Role |
|---|---|---|
| Lawrence Wagman, M.D. | St. Joseph Hospital of Orange | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph Hospital of Orange | Orange | California | 92868 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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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.
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Measure toxicity of Microwave Ablation through patient follow-up and assessment. |
| 30 Days |