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临床试验/NCT07380698
NCT07380698招募中不适用

The Effect of Dose and Storage Conditions of Indocyanine Green on Efficacy and Cost in Sentinel Lymph Node Mapping in Gynecological Cancer

Cukurova University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年10月3日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
Sentinel lymph node detection success rate associated with optimized indocyanine green (ICG) dosage and storage conditions.

研究概览

简要总结

This research will determine the impact of optimizing dosage and storage conditions for indocyanine green on health outcomes and will contribute to improving treatment processes in gynecological cancers. Ultrastaging will increase the detection of micrometastases. Furthermore, the cost impact of these optimizations will be evaluated. It will help develop more effective, safe, and cost-effective methods for sentinel lymph node mapping in gynecological cancers. Furthermore, significant savings in healthcare costs could be achieved.

详细描述

Indocyanine Green (ICG) is a substance used in many areas of medicine, particularly in surgical procedures for vascular imaging, organ function assessment, and the treatment of various types of cancer. In recent years, this substance has also gained significant ground in gynecological cancers. The use of indocyanine green in gynecological cancers is particularly notable for its role in identifying cancer cells, performing lymph node biopsies, and performing minimally invasive surgeries.

Indocyanine green has become an important tool in the treatment of gynecological cancers, particularly in lymph node biopsies and minimally invasive surgeries. Its applications are increasingly expanding as it helps identify the path of cancer spread and enhances surgical precision. This substance allows surgeons to perform more accurate and effective interventions while also accelerating patient recovery.

Sentinel lymph node (SLN) mapping is increasingly used in gynecologic cancers as a less morbid staging method, an alternative to systematic pelvic and para-aortic lymphadenectomy. Numerous prospective studies have demonstrated the accuracy and reliability of the SLN technique, particularly in endometrial, cervical, and vulvar cancers. Indocyanine green (ICG), when used in conjunction with near-infrared fluorescence imaging, has become the most frequently used method due to its high sensitivity and bilateral detection rate.Patients diagnosed with endometrial, cervical, and vulvar cancer and scheduled for SLN mapping will be included in the study; potential confounding variables such as patient characteristics (age, BMI, comorbidities), tumor characteristics (histology, stage), surgical approach, and surgeon experience will also be considered in the analyses. Indocyanine green administration in gynecological cancers:

  1. Standard dose (1.25 mg/mL, 4 x 1 mL)
  2. A low-volume protocol (1 mL) may be tried in low-risk cases for minimal intervention, but signal may be reduced.
  3. A high-volume application (8-10 mL) may be preferred in obese or signal-deficient patients; signal strength may be increased.
  4. A high concentration (2.5 mg/mL) has been found effective in some studies, but should be used with caution due to the risk of suppressing ICG's own fluorescence.

Standard storage conditions:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • cervical cancer, endometrial cancer, vulvar cancer, using indocyanine green, sentinel lymph node dissection

排除标准

  • 未提供

结局指标

主要结局

Sentinel lymph node detection success rate associated with optimized indocyanine green (ICG) dosage and storage conditions.

时间窗: Baseline (pre-procedure), perioperative/periprocedural period, and up to 24 weeks post-procedure.

次要结局

  • Impact of optimizing indocyanine green (ICG) dosage and storage conditions on total procedural cost.(Baseline (pre-procedure) and up to 24 weeks post-procedure.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ghanim Khatib

Associated Professor

Cukurova University

研究点 (1)

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