Feasibility Study of the (Intravenously Injected) Indocyanine Green (ICG) Imaging of Tumoral Implants in Patients With Peritoneal Carcinomatosis From Ovarian Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Feasibility study of the (intravenously injected) ICG imaging of tumoral implants in patients with peritoneal carcinomatosis from ovarian carcinoma
研究概览
简要总结
The purpose of this study is to determine if NIF fluorescent imaging is an effective approach to detect the gross ovarian tumoral tissues and peritoneal implants in Ovarian cancer patients.
详细描述
Primary objective:
Evaluation of the ability of NIR imaging to image and to detect the " viable " gross tumoral mass and/or peritoneal metastatic " implants " in women operated for ovarian carcinoma with peritoneal carcinomatosis after the IV injection of ICG ( which is approved for human use) the day before the operation.
Secondary objective:
Definition of the histological distribution (in the vessels, in the extravascular spaces, in specific cells) of IV injected ICG in the normal and pathological tissues (and, if any is demonstrated pre-operatively, in the nodes of these patients found fluorescent and removed).
however other goals of our project will be will be:
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients (either newly diagnosed, or relapsing) with histo-pathological diagnosis of ovarian carcinoma and peritoneal carcinomatosis who are candidate for "open" surgery, either after neo-adjuvant chemotherapy (80-90% of the cases), or in "first intent".
- •Informed consent form signed.
排除标准
- •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).
研究组 & 干预措施
ICG NIR imaging
see Summary and description iv injection of ICG
干预措施: iv injection of ICG (Drug)
结局指标
主要结局
Feasibility study of the (intravenously injected) ICG imaging of tumoral implants in patients with peritoneal carcinomatosis from ovarian carcinoma
时间窗: 1 year
Evaluation of the feasibility of NIF imaging to detect tumoral implants in patients with peritoneal carcinomatosis from ovarian carcinoma, the efficacy of this approach will be confirmed by histological test of the dissected tissue.
次要结局
未报告次要终点