Status:
TERMINATED
Radiofrequency Ablation in Breast Cancer
Lead Sponsor:
Hospital Universitari de Bellvitge
Conditions:
Breast Cancer
Eligibility:
FEMALE
40+ years
Phase:
NA
Brief Summary
Background/Main objective: Radiofrequency ablation (RFA) is a minimally invasive procedure widespread accepted in the treatment of different tumors, especially in the liver but its benefit is not yet ...
Detailed 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 th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2017
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02281812
Start Date
September 1 2013
End Date
July 1 2017
Last Update
June 4 2018
Active Locations (1)
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1
Hospital Universitario Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08908