Malignant neoplasm of breast of unspecified site
Conditions
Interventions
A prospective study to evaluate the efficacy of intersticial percutaneous laser therapy ( ILT) in patients with stage I breast cancer was conducted. Inclusion criteria were patients between 18 and 80
E02.594
Sponsors
Universidade federal de sao paulo
Sociedade Beneficente Israelita Albert Einstein - AmigoH
Eligibility
Sex/Gender
Female
Age
18 Years to 80 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcomes 1: Observe a complete ablation rate in more than 90% of cases and describe the average ablation observed per patient. Sample size calculation: among similar studies published between 2000 and 2008, we observed an inclusion of 92 patients (average of 30 patients per study) with an average ablation rate of 51% and standard deviation of 3%. Considering the objective of estimating the average percentage of necrosis and its 95% confidence interval, assuming a standard deviation similar to that of the aforementioned studies and a maximum error of 17% in the estimate, it would be necessary to observe at least 20 patients. ;Observed Outcomes 1: The present study included 18 patients from September 2015 to May 2018. Among them, 14 completed the protocol, with one of them having bilateral single lesions, totaling 15 carcinomas treated. Four patients were excluded (two had multifocal tumors on MRI, one was excluded due to claustrophobia preventing MRI, and one left the study due to a laser equipment failure during the procedure).The average ablation rate in the histopathological evaluation was 61.5% (ranging from 0 to 93%). | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 2: Observe sensitivity of MRI for identifying residual tumor above 90%. ;Observed Outcomes 2: In the four cases with an ablation rate greater than or equal to 85%, no residual enhancement was observed on MRI in three of them. On the other hand, among the 11 cases with an ablation rate below 85%, MRI was able to identify the presence of enhancement or residual nodules. Based on these results, the sensitivity of MRI for identifying residual tumor greater than 15% was 1.0, and the specificity was 0.84, with an accuracy of 93% for these characteristics. ;Expected Outcomes 3: Describe technical aspects of the procedure such as duration and adverse events observed. ;Observed Outcomes 3: The mean laser application time was 10.1 minutes per nodule (ranging from six to 13 minutes). No severe adverse events were recorded during the ablative procedure. After five to six hours post-procedure, 11 patients reported mild pain, while three reported moderate pain, which significantly improved with analgesics. The following day after the ablative procedure, six patients reported mild pain, and the other eight patients reported no pain. One patient experienced a grade 2 skin burn of approximately 0.6 x 0.6 cm, caused by inadequate coupling of the optical fiber to the puncture needle during laser application. The area was excised during surgery, and there were no further consequences or aesthetic damage beyond what was expected from the surgery. | — |
Countries
Brazil
Contacts
Public ContactDanielle Matsumoto
Centro de Ensino e Pesquisa Albert Einstein
Outcome results
None listed