Study of the (Intravenously Injected) Indocyanine Green Distribution in Tumour Bearing Breasts and in Axillary Pieces of Dissection of Patients Who Have Received Neoadjuvant Therapy for Histologically Proven Mammary Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- fluorescence intensity of tumoral lesions, scars and healthy tissues after IV injection of ICG in breast cancer patients after neoadjuvant therapy
研究概览
简要总结
We will verify if IV injected ICG may colour breast tumors and axillary lymph nodes after neoadjuvant therapy (chemo- or hormonotherapy)
详细描述
In the operating room:
ICG 0.25 mg/kg will be given as an iv injection at least 20 minutes before the beginning of the operation.
Optionally, dynamic NIR imaging centered on the tumor bearing breast will be acquired during the 15 minutes after injection (in comparison with standards of known fluorescence intensity).
Optionally and in case of tumorectomy, peroperative "in vivo" imaging of the surgical dissection will be acquired. The tumour and/or the mammary piece (and the axillary piece) of dissection will be directly imaged "ex vivo" using the PDE camera (in comparison with standards of known fluorescence intensity).
In the Laboratory of Pathology:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with histopathological diagnosis of mammary cancer who have received neoadjuvant therapy and are candidate, either for tumorectomy, or for mastectomy with complete axillary node dissection,
- •Informed consent form signed.
排除标准
- •Diagnosis of mammary cancer established, either by tumorectomy, or by "gross" biopsy,
- •Age less than18 years old.
- •Inability to give informed consent.
- •History of allergy or hypersensitivity against the investigational product (its active substance or ingredients), to iodine or to shellfish.
- •Apparent hyperthyroidism, autonomous thyroid adenoma, unifocal, multifocal or disseminated autonomies of the thyroid gland.
- •Documented coronary disease.
- •Advanced renal impairment (creatinine > 1,5mg/dl).
- •During the 2 weeks before the enrolment, concurrent medication which reduces or increases the extinction of ICG (i.e. anticonvulsants, haloperidol and Heparin).
- •Pregnancy, breastfeeding
研究组 & 干预措施
Indocyanine Green
intravenous injection of 0.25mg/kg Indocyanine Green just before surgery
干预措施: Indocyanine Green (Drug)
结局指标
主要结局
fluorescence intensity of tumoral lesions, scars and healthy tissues after IV injection of ICG in breast cancer patients after neoadjuvant therapy
时间窗: 1 week
次要结局
未报告次要终点