跳至主要内容
临床试验/NCT01314963
NCT01314963已完成不适用

Efficacy of a Novel, High-Sensitivity, Portable, Hand-Held Gamma Camera Used Intraoperatively for Identification of Sentinel Lymph Nodes With Lymphoscintigraphy

Stanford University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2008年6月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Relative Node Detection Sensitivity

研究概览

简要总结

This study evaluates the ability of a prototype intraoperative handheld gamma camera (pIHGC) to image (detect) sentinel lymph nodes (SLNs) in melanoma and breast cancer during surgical excision, as compared to standard of care intraoperative gamma probes (GP). The unit of study in this trial was SNLs rather individual participants. Each device was assessed for relative node detection sensitivity (S) of those SLNs.

详细描述

Lymphoscintigraphy is an accepted and commonly-performed procedure used for staging of certain cancers, especially melanoma and breast cancer. It involves injecting a small amount of radioactivity under the skin in order to identify lymph nodes which should be biopsied (ie, the "sentinel lymph node, SLN") to determine if cancer has spread. The study objective was to evaluate the potential benefit of a new, camera-based technology (prototype device) which allows actual images to be obtained intra-operatively in the identification of sentinel nodes.

Each device was assessed for relative node detection sensitivity (S), defined as the proportion of sentinel lymph nodes (SLNs) that were identified with each instrument, with the proportion determined as the number of true positives (TP) divided by the total evaluated (N).

研究设计

研究类型
Interventional
分配方式
Non Randomized
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
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Intraoperative handheld Gamma Camera (pIHGC)

Experimental

The prototype intraoperative handheld gamma camera (pIHGC)

干预措施: Prototype intraoperative handheld gamma camera (pIHGC) (Device)

Intraoperative handheld Gamma Camera (pIHGC)

Experimental

The prototype intraoperative handheld gamma camera (pIHGC)

干预措施: radioactive Tc99M (Radiation)

Gamma probes (GP)

Active Comparator

Standard of care intraoperative gamma probes (GP) currently in use.

干预措施: Lymphoscintigraphy with intraoperative gamma probes (GP) (Device)

Gamma probes (GP)

Active Comparator

Standard of care intraoperative gamma probes (GP) currently in use.

干预措施: radioactive Tc99M (Radiation)

结局指标

主要结局

Relative Node Detection Sensitivity

时间窗: 1 day

Relative node detection sensitivity (S) was defined as the proportion of sentinel lymph nodes (SLNs) that were identified with each instrument, with the proportion determined as the number of true positives (TP) divided by the total evaluated (N). The outcome result is expressed as the percentage for each device with 95% confidence intervals.

次要结局

未报告次要终点

研究者

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

John B. Sunwoo

Assistant Professor of Otolaryngology - Head and Neck Surgery

Stanford University

研究点 (2)

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