se of Laser Ablation in the treatment of inicial breast Cancer

Not Applicable

Terminated

Conditions: Malignant neoplasm of breast of unspecified site
C04

Registration Number: RBR-27y2rqq

Lead Sponsor: niversidade federal de sao paulo

Brief Summary: Background: Screening programs are changing the scope of breast cancer, with a growing number of patients diagnosed at a nearly stage. The current standard treatment (breast conservative surgery and radiation therapy) offers an excellent prognosis for these patients. Besides tumor removal, other techniques can be used to destroy a mass in place. A range of minimally invasive techniques holds promise on local breast tumor ablation (i.e., thermotherapy and cryotherapy). Previous studies with Interstitial laser thermotherapy (ILT) for breast cancer report mean ablation rates between 33% to 87%. Most common cited causes for failure are equivocal tumor size estimation, inadequate technique and the learning curve. Objective: The primary objective aimed to evaluate the efficacy and safety of Ultrasound (US)-guided ILT in the treatment of stage I breast cancer. Secondarily, the study sought to standardize the technical criteria applied, identify histopathological and immunohistochemical criteria that can predict treatment success and evaluate the effectiveness of magnetic resonance imaging (MRI) in estimating tumor volume and residual lesion. Methods: A prospective study including patients with Stage I invasive breast cancer, presented as a unique lesion was conducted. MRI and US were used to estimate the primary tumor volume and rule out multicentric/ multifocal disease. ILT ablation was performed through percutaneous laser optical fibers with a US-guided insertion. The programmed power was 5 W and the energy should reach 2000 J per fiber. Post procedure image reevaluation included US and MRI. The definitive proposed surgical treatment was carried out 8 to13 days after the ILT ablation. Results: Eighteen patients were included in the study, of whom 14 (with 15 lesions) completed the protocol. The mean tumor size was 13.7mm (4-20mm). The mean treatment time was 10.1 minutes and all patients went home the same day, reporting only mild (78%) or moderate (22%) pain. The mean ablation index, was 61,5% (0-93%) and when only tumors under 15 mm were considered the mean ablation index was 75% (30%-93%). MRI sensitivity and specificity to detect residual tumors were 1.0 and 0.84, respectively, when residual tumors were larger than 15% from the original tumor. Conclusions: These results suggest that laser therapy can eliminate viable neoplastic tissue in vivo and MRI appears to be an appropriate method for selecting patients and evaluating any residual tumor. To achieve better results, standardization in patient selection and in technical parameters should be considered. There are several advantages of ILT for breast cancer treatment, including preserving the structure and function of breast, no bleeding and no scaring. More studies refining the technique should be conducted to allow the implementation of ILT as an alternative to surgical treatment in early breast cancer.

Detailed Description: Not available

Recruitment & Eligibility

Status: Terminated

Sex: Female

Target Recruitment: Not specified

Inclusion Criteria

Women aged between 18 and 80 years with unifocal stage I breast cancer (less than 2 cm), confirmed by image methods ( mammogram, ultrasound and magnetic resonance), and core biopsy

Exclusion Criteria

Patients over 80 years old or with comorbidities that contraindicate the surgical procedure; Multifocal/multicentric tumors detected by any imaging method; Tumors measuring more than 2 cm by any imaging method; Tumors located less than 1 cm from the skin or pectoral muscle; Inability to commute between the treatment centers; Use of anticoagulants or antiplatelet agents up to one week before the procedure (laser or surgery); Psychiatric illness that impairs understanding and adherence to treatment