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临床试验/NCT02260349
NCT02260349撤回3 期

Interest of Indocyanine Green in the Neoplastic Prostatic Tissue Characterization and the Peroperative Surgical Margins Detection During a Radical Prostatectomy.

Centre Hospitalier Universitaire de Saint Etienne0 个研究点开始时间: 2014年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
撤回
主要终点
Sensitivity of indocyanine green

研究概览

简要总结

Prostate cancer, with more than 70,000 new cases and 8900 deaths a year in France, is a major public health problem. Until 28% of patients treated with surgery will present a positive surgical margin resulting in an incomplete clearance of the tumoral process and exposing so the patient at a local, systemic recurrence and increased morbidity. An increasing number of international publications have shown (ICG) was interesting for the detection of the sentinel lymph node, in the surgery of tumors of type hepatocarcinoma and liver metastases from colorectal diseases, but also in the surgery of the kidney, bladder or breast. ICG has affinity for tumor and tissues around the tumor related to micro-vascular histology for a localized and specific deposit (EPR effect).

The detection of ICG 's deposits is now possible with to the use of a device which allow to visualize the infra-red fluorescence (NIR; Near Infra-Red) for objects larger than 0.15 mm. Thanks to this feature, the location of residual tumor tissue when performing a radical prostatectomy could be made much easier.

详细描述

The ability of ICG to detect a surgical margin positive intraoperatively has never be evaluated. We want to perform a monocentric prospective ex-vivo pilot in order to evaluate the diagnostic performance of fluorescence in the detection of surgical margins compared to pathologic analysis. This study will be conducted in 37 patients operated on for a radical prostatectomy after systemic injection of 0, 25 mg/Kg of ICG 24 h before the surgery. The fluorescence analysis will be performed in the operation room and then specimen will be sent to the laboratory for an analysis as usual. Two pieces of prostate will be prelevated according to a protocol. The histopathological procedure will be performed without knowledge of fluorescence analysis. Except the ICG injection the medical procedure won't be changed.

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
Male
接受健康志愿者

入选标准

  • Patients with prostatic cancer proved by biopsy and needing total prostatectomy with or without curettage.
  • Patient affiliated to a social security scheme
  • Patient has given its informed consent

排除标准

  • contra-indication to surgery
  • non confirmed adenocarcinoma diagnostic
  • antecedent of prostatic cancer treatment
  • antecedent of pelvic surgery

研究组 & 干预措施

patient with Indocyanine green infusion

Experimental

Infusion of Indocyanine Green 0,25 mg/Kg 24h before prostatic surgery

干预措施: indocyanine green infusion (Drug)

结局指标

主要结局

Sensitivity of indocyanine green

时间窗: 24h after indocyanine green infusion

Sensitivity (true positive) of the fluorescence due to indocyanine green to detect neoplasm tissue in prostatic biopsy compared to histological analysis

次要结局

  • Specificity of indocyanine green(24h after indocyanine green infusion)

研究者

申办方类型
Other
责任方
Sponsor

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