Performance Assessment of the Fluorescence Technique Alone in the Search for the Sentinel Node in Breast Surgery, Compared to the Use of the Combined Fluorescence and Isotopic Method
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 392
- 试验地点
- 10
- 主要终点
- Diagnostic performance (Sensitivity and Specificity) of the indocyanine green fluorescence (ICG) method
研究概览
简要总结
Cohort, interventional, multicenter, non-randomized study to compare the performance of the ICG fluorescence technique (ICG) alone to the combined ICG + isotopic technique in the detection of sentinel node.
Comparison of the performances of two techniques used in current practice, without modification of the patients' care plan. Indeed, all patients receive both techniques, but the protocol allows to standardize the collection of the performances of each of the two techniques in order to compare them.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient over 18 years of age on the day of inclusion,
- •Presenting with breast cancer,
- •Fulfilling the Sentinel Node search criteria of:
- •Patient with carcinoma in situ with high risk of microinvasion:
- •nodular presentation, high grade with necrosis,
- •suspicion of microinvasion at biopsy,
- •radiological size of more than 40 mm,
- •need for mastectomy or extensive resection requiring a complex oncoplasty surgery (no size criteria, at the surgeon's discretion)
- •Patient with T1-T2 invasive carcinoma AND no lymph node involvement according to Tumor-Node-Metastasis (TNM) classification (N0) on clinical and imaging (negative axillary echo or negative lymph node biopsy):
- •unifocal or bifocal proximal tumor
- •< 5 cm (clinical), palpable or non-palpable (subcentimetric allowed)
- •in case of neoadjuvant chemotherapy: before or after if N0 and negative axillary echo or negative biopsy
- •Benefiting from a French social security system
- •Having been informed of the study and having freely given their informed consent to participate in the study.
排除标准
- •Pregnant or breastfeeding patient
- •Patient not eligible for the sentinel node procedure (contraindication to surgery, N+ and/or M+ clinical or radiological, T3 and more, history of homolateral breast cancer surgery)
- •Patient under guardianship or curators
- •Patient under court protection
- •Patient who does not understand French
- •Patient already included in the study
结局指标
主要结局
Diagnostic performance (Sensitivity and Specificity) of the indocyanine green fluorescence (ICG) method
时间窗: At time of surgery
The main objective is to evaluate the diagnostic performance (Sensitivity and Specificity) of the indocyanine green fluorescence (ICG) method alone as a sentinel node marker in non-metastatic breast cancer, compared to the method coupling technetium-99m isotopic research (TC) to fluorescence (Gold Standard in the study centers). The suspicious node bundles, which will have been removed after identification by 1) ICG alone, 2) TC alone or 3) manually, can be classified in a contingency table, according to the first method (the sequence) with which they are detected. The Sensitivity / Specificity pair will then be used to : 1. Estimate the area under the curve (AUC) of the ICG method alone, and its 95% confidence interval. 2. Estimate the positive and negative predictive values of ICG alone, using the prevalence of metastatic lesions.
次要结局
- Frequency and factors associated with the occurrence of false negatives (FN) related to the use of ICG alone (fluorescence tracking failure alone)(At time of surgery)
- Causes of premature use of the isotope method (moving to the second stage of tracking) before the first stage of tracking (ICG method) has been completed.(At time of surgery)
- Interest of the ICG technique alone compared to the combined technique for the detection of metastases.(Upon receipt of the anatomopathology results)
- Surgeon's perception of the usefulness and self-perceived satisfaction of ICG method alone, compared with the combined technique (ICG+TC).(At time of surgery)
- Frequency of detection on table by multispectral camera, of ganglions first detected only by isotopic method.(At time of surgery)