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临床试验/NCT03545334
NCT03545334已完成不适用

A Diagnostic Sensitivity Study Comparing Intradermal ICG and NIRFI With Intradermal Technetium 99m and Traditional Lymphoscintigraphy for Transcutaneous Identification of Sentinel Lymph Nodes in Malignant Melanoma

Insel Gruppe AG, University Hospital Bern2 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2017年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
93
试验地点
2
主要终点
Correlation of sentinel lymph nodes identified by lymphoscintigraphy vs. VisionSense near-infrared-fluorescence-imaging.

研究概览

简要总结

A diagnostic sensitivity study comparing intradermal indocyanine green (ICG) and near infrared fluorescence imaging (NIRFI) with intradermal technetium 99m and traditional lymphoscintigraphy (LS) for transcutaneous identification of sentinel lymph nodes (SLN) in malignant melanoma - a prospective Phase II clinical study in a single center.

详细描述

Switzerland has the highest rate of new melanomas in Europe (19.2 per 100,000). Melanomas have the worst prognosis of all skin cancers. The current treatment depends on the histological diagnosis after a biopsy and is primarily related to the tumor thickness (Breslow Score), the tumor cells in division (mitosis rate), the substance defect of the skin (ulceration), the occurrence of regression, and the age of the patients. The initial treatment is performed by surgical removal with a safety margin of macroscopically healthy skin around the tumor. If the tumor thickness is more than 1 mm or more than 0.7 mm associated with a high mitosis rate in younger patients, ulcerations, regression or Clark Level IV / V, then current melanoma guidelines suggest that the patient undergoes sentinel lymph node biopsy (SLKB) as this is most likely the first site where metastases spread. Merkel cell carcinoma is a very aggressive, neuroendocrine skin tumor with a mortality rate of about 33% after 3 years. Due to the frequent lymphatic metastases, SLNB is highly recommended in all patients in order to better assess their prognosis. The gold standard technique to identify SLKs is to inject the radioisotope Technetium-99m around the primary tumor into the skin. The patient is then scanned to determine the position of the SLK after approximately 30 and 120 minutes. Other teams have attempted to identify transcutaneous SLK with ICG and NIRFI, but have concluded that ICG fluorescence technique is not reliable in patients with high BMI or a primary tumor with lymph drainage in the axillary lymph node region. This study aims to evaluate a medical device that uses an improved technology compared to previous studies (stereoscopic 3D high definition for both fluorescence and visible light imaging). The investigators hope is that by applying similar principles SLKs can be identified through the use of transcutaneous fluorescent dye injections and NIRFI.

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

盲法说明

The surgeons performing SLNB will be the blinded persons. The results of the lymphoscintigraphy will not be marked on the patient's skin as usual and no preoperative access to the images will be granted to the surgeons.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Malignant melanoma patients having one of the following characteristics:
  • Breslow score ≥ 1 mm
  • Breslow score ≥ 0.7 mm associated with ulceration
  • Breslow score ≥ 0.7 mm associated with regression
  • Breslow score ≥ 0.7 mm associated with Clark Level IV / V
  • Breslow score ≥ 0.7 mm associated with mitotic rate ≥ 1/mm2 in young patients
  • Merkel cell carcinoma

排除标准

  • Age < 18 years
  • Pregnancy and breastfeeding (pregnancy test to be performed for women of child-bearing potential, defined as women who are not surgically sterilized/ hysterectomized, and/or who are postmenopausal for less than 12 months)
  • Known allergy to ICG or Iodine
  • Previous chemotherapy, radiotherapy or surgery to the lymph nodes of interest
  • Lack of capacity to provide informed consent
  • Current enrolment in any other interventional study

结局指标

主要结局

Correlation of sentinel lymph nodes identified by lymphoscintigraphy vs. VisionSense near-infrared-fluorescence-imaging.

时间窗: one hour

To determine whether the VisionSense NIRFI technology can transcutaneously identify SLNs as effectively as LS.

次要结局

  • Correlation of sentinel lymph nodes identified by lymphoscintigraphy vs. VisionSense near-infrared-fluorescence-imaging in specific anatomical locations and in defined patient groups (e.g. groups defined based on BMI, sex, age).(one hour)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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