Breast Cancer Clinical Trial
Official title:
Impact of Radiofrequency Ablation on Surgical Margins in Early Stage of Malignant Breast Tumors
NCT number | NCT02281812 |
Other study ID # | AC133/12 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2013 |
Est. completion date | July 2017 |
Verified date | May 2018 |
Source | Hospital Universitari de Bellvitge |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 well-known in breast cancer.
Our main objective is to evaluate the usefulness of RFA in < 2cm malignant breast tumors to
reduce the proportion of positive margins.
Methodology: The investigator propose a single-center, single-blind, phase I and II
randomized controlled trial. Phase I:Security of the cool-tip cluster electrode assessing the
potential adverse effects in three stages: initial,intermediate and final. Phase II:
Randomized clinical trial, 2 parallel groups with 37 patients in each one.
Experimental group: percutaneous RFA previous to conventional lumpectomy. Control group:
conventional surgery with lumpectomy. The number of positive margins in both groups, and the
need of extending margin resection will be assessed intraoperatively. Inclusion criteria:
women >40 years, infiltrating ductal breast carcinoma by biopsy. The tumor must be unique,
visible by ultrasound, smaller than 2cm and located > 1 cm from the chest wall and the skin.
Patients will be followed up for a period of two years to assess cosmetic result, short -term
and long -term complications and recurrences.
Expected results: The "cool-tip" (cluster) ablation method reduces by at least 30% the risk
of intraoperative extensions for positive margins during lumpectomy compared to conventional
surgery in breast tumors with a diameter < 2 cm.
Therefore this procedure may reduce the risk of second surgeries and the removed volume of
tissue.Consequently the final cosmetic result should be improved.
Status | Terminated |
Enrollment | 40 |
Est. completion date | July 2017 |
Est. primary completion date | July 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 40 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitario Bellvitge | Hospitalet de Llobregat | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Hospital Universitari de Bellvitge |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intraoperative free margins (distance between the tumor and the margin in order to indicate if extensions are mandatory.) | 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. | 1 hour | |
Secondary | Security of RFA (Adverse effects and cosmetic result) | Adverse effects and cosmetic result will be evaluated 15 days after the procedure | 15 days | |
Secondary | Efficacy of RFA (Tumoral viability in the ablation zone) | Tumoral viability in the ablation zone will be evaluated by NADH-diaphorase, COX and tunel | 7 days |
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