Feasibility of Holmium-166 Microspheres for Selective Intra-tumoural Treatment in Head and Neck Cancer: Biodistribution and Safety in Patients With Malignancy of the Tongue
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- UMC Utrecht
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Total amount of activity leakage (in percentage) in the oral cavity rinsing fluid.
研究概览
简要总结
The main objective is to establish the feasibility of 166-Holmium microspheres for intratumoral injections in oral squamous cell carcinoma (OSCC) of the tongue.
Participants will receive intratumoral injections with a low radioactive 166-Holmium microspheres followed by surgical resection
详细描述
166-Holmium microspheres poly lactic acid microspheres are currently used in selective internal radiation therapy. These microspheres emits beta radiation. The majority of the radiation dose will be absorbed within 3.2 mm with a maximum penetration in tissue of 9 mm. Therefore this can result in a high local tumor ablative dose with minimal dose to healthy adjacent tissue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Patients must have given written informed consent.
- •Aged 18 years and over.
- •Confirmed histological diagnosis of squamous cell carcinoma of the tongue.
- •primary tumor, regional nodes, metastasis (TNM) stage T1-2 Nx M
- •Eligible for local surgery with curative intent.
- •World Health Organization (WHO) Performance status 0-2.
排除标准
- •Previous oncologic surgery and/or external beam radiation therapy on the tongue and oral floor.
- •Major surgery (Oro-facial) within the past 4 weeks or incompletely healed surgical incisions before starting study therapy.
- •Any unresolved toxicity greater than National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events (CTCAE version 4.03) grade 2 from previous anti-cancer therapy.
- •Pregnancy or nursing (women of child-bearing potential).
- •Patients suffering from psychic disorders that make a comprehensive judgment impossible, such as psychosis, hallucinations and/or depression.
- •Previous enrolment in the present study.
研究组 & 干预措施
Holmium-166 microspheres
Single session of 4 intratumoral injections consisting of 0.1-0.3 ml radioactive Holmium-166 microsphere suspension with a total activity 30 Megabecquerel, 7-12 days prior to surgical resection.
干预措施: Holmium-166 (poly L lactic acid) microspheres (Device)
结局指标
主要结局
Total amount of activity leakage (in percentage) in the oral cavity rinsing fluid.
时间窗: upto 5 minutes after administration
次要结局
- Occurrence of (serious) adverse events(Between administration and resection of the tumor (max 12 days))
- The biodistribution of Holmium-166 microspheres after intra-tumoural injection(3 hours after administration)
研究者
Marnix Lam
Professor Nuclear medicine
UMC Utrecht