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To validate the efficacy and safety of the cool-tip ablation method for breast tumors smaller than 2 cm.
A prospective, phase II-III study, which will include a series of cases of 30 patients. The hospitals involved will be Bellvitge University Hospital and Hospital del Mar.
Efficacy was evaluated according magnetic resonance image and biopsy of the breast 1 month after the procedure.
Patients will be followed up over a 2-year period to assess cosmetic results, short and long-term complications and possible recurrences.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiofrequency Ablation Tumor | Experimental | Radiofrequency Ablation of breast cancer tumour by Cool-tip electrode. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cool-tip electrode for Radiofrequency Ablation | Device | Radiofrequency ablation of the tumour in the surgery group, associated whith axillary surgery when applicable |
|
| Measure | Description | Time Frame |
|---|---|---|
| MRI post-RFA | Magnetic Resonance Image after Radiofrequency ablation to confirmate complete disappearance of tumor contrast enhancement (residual mm). | "1 month" |
| BAG post-RFA | Breast biopsy after Radiofrequency to confirmate absence of viable tumor tissue using NADH, CK18 and CK19 stainings (tumor viability scale: 0, <25%, 25-50%, 50-75%, > 75%). | "1 month" |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Effects | Adverse effects related to radiofrequency | "1 month" |
| Quality | Breast-Q | "1 month" |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amparo Garcia-Tejedor, MDPhD | Hospital Universitari Bellvitge | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital del Mar | Barcelona | Barcelona | 08003 | Spain | ||
| Hospital de Bellvitge |
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| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| ID | Term |
|---|---|
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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Radiofrequency ablation
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| L'Hospitalet de Llobregat |
| Barcelona |
| 08907 |
| Spain |