Preoperative MRI and Magnetometer-guided Intraoperative Sentinel Lymph Node Detection With Superparamagnetic Iron Oxide Nanoparticles (SPIO) in Patients With Vulvar Cancer - a Feasibility Study (POSVUC Pilot)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Sentinel lymph node identification
研究概览
简要总结
The aim of the feasibility study is to evaluate whether SPIO-MRI and a magnetometer could be a potential substitute to the routine dual technique in pre-and intraoperative SLN localization. Secondary, to explore if SPIO-MRI could predict lymph node status in comparison to histopathological analysis.
详细描述
Sentinel lymph node (SLN) biopsy is the routine procedure for nodal staging in early vulvar squamous cell carcinoma (VSCC) in the absence of clinical signs of lymph node metastasis. The gold standard technique for identifying SLN utilizes Technetium (Tc99m) lymphoscintigraphy and blue dye. An alternative method has emerged using superparamagnetic iron-oxide (SPIO) and magnetic resonance imaging (MRI).
This study aims to enroll 20 VSCC patients scheduled for the SLN procedure. Determination of the minimal dosage of SPIO required to avoid excessive MRI artifacts while still identifying the SLN. Intraoperative SLN detection with a magnetometer will be compared with the gold standard gamma probe.
As secondary objective, in addition to determining the SNL, MRI analysis of the nodal status will be evaluated for potential metastasis and compared to histopathological results.
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed primary VSCC <4 cm, candidates for surgery with SLNB Age above 18
- •Signed and dated written consent before the start of specific protocol procedures.
- •ECOG performance status 0-2
排除标准
- •Contraindications for MRI such as electronic implants or severe claustrophobia
- •Hip replacement
- •Iron overload disease
- •Known hypersensitivity to iron or dextran compounds
- •Inability to understand given information and give informed consent or undergo study procedure
结局指标
主要结局
Sentinel lymph node identification
时间窗: Within 30 days after SPIO injection.
The number of lymph nodes identified preoperatively with SPIO-enhanced MRI and intraoperatively with a magnetometer compared to Technetium-99m scintigraphy and blue dye.
次要结局
未报告次要终点
研究者
Katja Stenström Bohlin
Principal Investigator
Sahlgrenska University Hospital