Radiofrequency Ablation in Breast Cancer
Mots clés
Abstrait
La description
Main objectives of the project:
- To evaluate the usefulness of radiofrequency ablation (RFA) to achieve a lower percentage of positive margins.
- To validate clinically the efficacy and safety of the method in breast tumors smaller than < 2 cm.
Specific objectives of the project:
1. To demonstrate that , after RFA, clear margins are increased in the intraoperative pathological analysis compared to conventional surgery.
1. To quantify the number of positive margins requiring intraoperative extension in each patient, comparing the ratio in both groups.
2. To quantify the percentage of patients requiring intraoperative extension compared in both groups.
2. To demonstrate a reduction in the volume of breast tissue removed after RFA compared to conventional surgery.
1. Comparing in both groups the anteroposterior, transverse and craniocaudal diameters of the excised specimen, measured in cm, and to calculate the volume.
2. Tumor weight in grams (including extensions) will be measured to compare the weights in both groups.
3. To evaluate the differences in cosmetic outcome after RFA versus conventional surgery.
a. An international scale will be used and the scores will be compared. There will be two independent assessments, one for the physician and another for the patient.
4. To demonstrate the effectiveness of the RFA by cluster "cool-tip" electrode in the experimental group.
1. RFA is considered as complete when no viable tumor tissue is evidenced by oxidation-reduction reaction mediated by NADH-diaphorase after surgical resection. Mitochondrial dysfunction will be also evaluated by semiquantitative and quantitative method using the enzyme cytochrome c oxidase or Complex IV (COX) and tunel. Any residual viable tumor tissue will be considered as incomplete RFA.
2. Risk factors for incomplete ablations will be analyzed, especially tumor vascularization.
5. To demonstrate the safety of RFA by cluster "cool-tip" electrode in breast cancer tumors a. To quantify all side effects that may occur after the RFA and / or surgery and to correlate the complication rate in each group with severity.
Rendez-vous
| Dernière vérification: | 04/30/2018 |
| Première soumission: | 10/29/2014 |
| Inscription estimée soumise: | 11/02/2014 |
| Première publication: | 11/03/2014 |
| Dernière mise à jour soumise: | 05/30/2018 |
| Dernière mise à jour publiée: | 06/03/2018 |
| Date de début réelle de l'étude: | 08/31/2013 |
| Date d'achèvement primaire estimée: | 06/30/2017 |
| Date estimée d'achèvement de l'étude: | 06/30/2017 |
Condition ou maladie
Intervention / traitement
Procedure: RFA group
Phase
Groupes d'armes
| Bras | Intervention / traitement |
|---|---|
| Experimental: RFA group A percutaneous (utlrasound-guided) radiofrequency ablation (RFA) of the tumor will be performed by the radiologist under general anesthesia. Immediately after, excision of the tumor with appropriate margin will be accomplished. | Procedure: RFA group After tumor ablation and excision of the tumor, the pathologist performed a macroscopic study of the specimen,measuring the distance between the tumor and the margin in order to indicate if extensions are mandatory. Secondly and delayed, margins will be evaluated microscopically by H&E stain. Furthermore, the tumoral viability in the ablation zone will be evaluated by NADH-diaphorase, COX and tunnel. |
| No Intervention: Control group Normal excision of the tumor according to the protocol |
Critère d'éligibilité
| Âges éligibles aux études | 40 Years À 40 Years |
| Sexes éligibles à l'étude | Female |
| Accepte les bénévoles en santé | Oui |
| Critères | Inclusion Criteria: - Breast single tumor, - Clearly visible by ultrasound, - Diameter < 2 cm - Located >1 cm from the chest wall and skin; - Ductal carcinoma according to previous biopsy, - < 20% of intraductal carcinoma Exclusion Criteria: - Breast cancer in men; - Personal history of ipsilateral breast cancer; - Age <40 years; - Pregnancy or breastfeeding; - Suspicion of intraductal extension or multifocality by mammography or MRI; - Tumour not visible by ultrasound; - Diameter > 2 cm; - Distance to muscle or skin <1 cm; - Lobular carcinoma; - Intraductal carcinoma in > 20% of the biopsy sample - Patients undergoing neoadjuvant chemotherapy or hormonotherapy. |
Résultat
Mesures des résultats primaires
1. Intraoperative free margins (distance between the tumor and the margin in order to indicate if extensions are mandatory.) [1 hour]
Mesures des résultats secondaires
1. Security of RFA (Adverse effects and cosmetic result) [15 days]
2. Efficacy of RFA (Tumoral viability in the ablation zone) [7 days]
