Prospective Clinical Study to Identify Secondary Sentinel Lymph Nodes in Patients With N1/N2b Oral Cavity or H&N Skin Cancers Using Patent Blue V and Indocyanine Green Dyes (preReDSeL Study)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Percentage of cases where the histopathological analysis of the dyed specimens confirms the presence of a lymph node
研究概览
简要总结
Head and neck (H&N) cancer has a poor prognosis and high morbidity with ~50% survival and frequent treatment resistance. Most deaths result from local or loco-regional progression rather than distant metastasis. Lymphatic spread to regional lymph nodes (RLNs), especially with extra-nodal extension (ENE), is a key predictor of poor outcomes. Current imaging techniques often miss micrometastases, leading to extensive but sometimes unnecessary neck treatments. Sentinel lymph node biopsy (SLNB) offers a precise method to detect early spread but is not yet widely adopted. Identifying second-echelon sentinel nodes-those receiving drainage from primary or first-tier nodes-may further refine treatment. The preReDSeL study evaluates the use of dyes (indocyanine green and Patent Blue V) for detecting these nodes. Success could reduce morbidity and guide tailored surgical/radiation therapy. The follow-up ReDSeL study will assess the clinical value of these findings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 否
入选标准
- •Age ≥18 years
- •Operable SCC located in the oral cavity or the skin of the H&N region, with one or two LNM
- •Primary disease
- •ECOG performance status 0-2
- •Signed study informed consent form for participation
排除标准
- •Non-operable tumors or contraindication to surgery
- •Previously treated head and neck cancer. Note: neoadjuvant treatment is not an exclusion criterion
- •Known hypersensitivity/allergy to triphenylmethane-based (Blue) dyes or to any of their components
- •Known hypersensitivity/allergy to indocyanine green or sodium iodide or iodine
- •Patients with known hyperthyroidism, thyroid autonomy (e.g., autonomous adenoma), or any thyroid disorder that may lead to increased iodine uptake
- •Patients with severe renal impairment (e.g., estimated glomerular filtration rate <30 mL/min/1.73 m²)
- •Patients receiving beta-blocker therapy, as these medications may mask or reduce the response to anaphylactic reactions induced by dye injection
- •Pregnancy and/or ongoing breastfeeding
- •Any reason that would interfere with the patient's well-being and treatment as assessed by the investigator
研究组 & 干预措施
Secondary lymph node detection
干预措施: Patent blue V dye injection (Drug)
Secondary lymph node detection
干预措施: Indocyanine green dye injection (Drug)
结局指标
主要结局
Percentage of cases where the histopathological analysis of the dyed specimens confirms the presence of a lymph node
时间窗: During surgery (from dye-injection until end of surgery)
Percentage of cases where the secondary sentinel lymph node status corresponds to the presence of disease in the rest of the dissected lymph nodes based on histopathology analysis
时间窗: During surgery (from dye-injection until end of surgery)
次要结局
未报告次要终点
研究者
Christian Simon
Professor
Centre Hospitalier Universitaire Vaudois