Validation of ICG-99mTc-nanoscan as hybrid tracer for sentinel node biopsy - NANOSCAN
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- To demonstrate concordance between the SN visualization of 99mTc-nanoscan and ICG-99mTc-nanoscan on preoperative lymphoscintigraphy and SPECT/CT imaging, expecting an average of 3 sentinel nodes per patient. Discordance is defined as more than 1 sentinel node not detected coherently by the tracers.
研究概览
简要总结
To demonstrate concordance between the SN visualization of 99mTc-nanoscan and ICG-99mTc-nanoscan on preoperative lymphoscintigraphy and SPECT/CT imaging, expecting an average of 3 sentinel nodes per patient. Discordance is defined as more than 1 sentinel node not detected coherently by the tracers.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patient who will undergo a sentinel node procedure in routine care.
- •Patients > 18 years;
- •Patients presenting with: a primary cutaneous melanoma of head/neck or upper part of the trunk or extremities; OR patients presenting with a primary oral cavity malignancy T1-2N0 OR patients with primary penile cancer
- •Patients with clinical N0 stage;
- •Patients scheduled for a sentinel node biopsy prior to (re-)excision of the primary lesion
- •Patients in which ICG-99mTc-nanoscan would be used in routine care or a research setting.
排除标准
- •Patients with known allergy to patent blue dye
- •Patients who are pregnant or breast-feeding mothers
- •History of hypersensitivity reactions to products containing human serum albumin
- •History of iodine allergy
- •Hyperthyroid or thyroidal adenoma
- •Kidney insufficiency
- •Incapacity or unwillingness of participant to give written informed consent;
结局指标
主要结局
To demonstrate concordance between the SN visualization of 99mTc-nanoscan and ICG-99mTc-nanoscan on preoperative lymphoscintigraphy and SPECT/CT imaging, expecting an average of 3 sentinel nodes per patient. Discordance is defined as more than 1 sentinel node not detected coherently by the tracers.
To demonstrate concordance between the SN visualization of 99mTc-nanoscan and ICG-99mTc-nanoscan on preoperative lymphoscintigraphy and SPECT/CT imaging, expecting an average of 3 sentinel nodes per patient. Discordance is defined as more than 1 sentinel node not detected coherently by the tracers.
次要结局
- Number of higher-echelon nodes visualized on preoperative lymphoscintigraphy and SPECT/CT imaging for both tracers (ICG-99mTc-Nanoscan and 99mTc-Nanoscan); 99mTc-Nanoscan is used as reference tracer.
- Concordance between intraoperative fluorescence and radioactive findings, using: Number and intensity of the fluorescent nodes at time of excision; Number and radioactive signal intensity of the radioactive nodes at time of excision
研究者
Dr. O. Brouwer
Scientific
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting