NCT03449615Unknown不适用
Isotopic Versus Magnetic Intraoperative Node Evaluation in Cutaneous Malignant Melanoma
Sociedad Española de Oncología Quirúrgica1 个研究点 分布在 1 个国家目标入组 186 人开始时间: 2015年12月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 186
- 试验地点
- 1
- 主要终点
- SN detection
研究概览
简要总结
This study has been designed to validate a non-radioactive method to identify the sentinel lymph node using a superparamagnetic iron-oxide (SPIO) tracer respect to the traditional isotopic method. Both methods are used in every included patient and each patient is its own control.
详细描述
- Injection of the isotopic tracer in standard form and in the usual preoperative period (hours-day).
- Identical injection in three-four punctures of 2 mL of Sienna+ ® and local massage of 5-10 minutes.
- Optional: colorant injection in standard form. Local massage of 5-10 minutes.
- After 20 minutes: transcutaneous measurement with SentiMag®
- Valuing territories (lymphoscintigraphy information?)
- Surgical identification measures:
- st with SentiMag®
- nd with gamma detection probe
- Ex vivo check and HRD record
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (>18 years of age),
- •with diagnosis of cutaneous melanoma and
- •in which SLNB is indicated as a staging method, and
- •with cN0 result after clinical-echographic-cytohistological evaluation.
排除标准
- •Previous treatment with systemic therapy.
- •Recent previous surgery (<3 months) in the area susceptible of lymphatic drainage from the melanoma.
- •Intolerance or hypersensitivity to iron or dextran compounds.
- •Impossibility of use of radioisotope.
- •Existence of pathology related to elevation of organic iron (hemosiderosis, hemochromatosis, iron deficiency anemia of metabolic or circulatory origin).
- •Implantation of pacemakers or partially or totally metallic thoracic implants.
- •Treatment with iron chelators (deferasirox, deferoxamine, ...).
结局指标
主要结局
SN detection
时间窗: During surgery
Detection of potential sentinel nodes using both methods (isotopic and ferromagnetic tracers). Máximum register of isotopic and ferromagnetic measurement will be the main criteria.
次要结局
- SN agreement(During surgery)
研究者
Antonio Piñero-Madrona
SEOQ Researcher
Sociedad Española de Oncología Quirúrgica
研究点 (1)
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