ACTRN12620000831987已完成未知
Magnetic Sentinel Lymph Node Mapping in Oral Squamous Cell Carcinoma: A Phase I Feasibility and Validity Clinical Trial
Central Adelaide Local Health Network trading as Royal Adelaide Hospital0 个研究点目标入组 15 人开始时间: 2020年8月21日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Diagnosis
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Age 18 or older
- •- Willing to provide informed consent
- •- ECOG status 0-2
- •- Biopsy proven T1-T2 oral SCC (tongue, RMT, buccal mucosa, FOM, hard palate)
- •- Clinically and radiologically N0 neck on contrast enhanced CT or gadolinium enhanced MRI +/- (USS or FDG PET)
- •- No distant metastases
- •- Primary tumours amenable to surgical resection
排除标准
- •- Serious medical comorbidities or other contraindications to surgery +/- adjuvant therapy
- •- Advanced T-stage primary tumour (>T2)
- •- Primary tumours not amenable to surgical resection
- •- Previous HNSCC
- •- Previous head and neck radiotherapy at any time
- •- Lip involvement
- •- Allergy or Intolerance to iron oxide or dextran compounds
- •- Metal implant close to site of sentinel lymph node
- •- Iron overload disorder
- •- Standard contraindications to MRI scanning
- •- Pregnant or lactating women
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