Sentinel Node Localization in Larynx and Pharynx Cancers After Flexible Endoscopy-guided Tracer Injection: a Feasibility Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Generation of SPECT-images of sufficient quality for localization of the sentinel node(s) after peritumoral Tc-99m-nanocolloid injection guided by flexible endoscopy.
研究概览
简要总结
This study explores the feasibility of sentinel lymph node identification in pharynx and larynx cancers using flexible endoscopy-guided tracer injection.
详细描述
The presence of lymph node metastases has a large impact on prognosis and treatment in head-and neck cancer (HNC) patients and necessitates treatment intensification. However, despite increased spatial resolution of current imaging techniques, around 20% of patients with a pre-operative clinically negative neck will have occult metastases in the neck dissection specimen. It is therefore that, when patients are treated with radiotherapy, the neck is almost always included in the target volume, also when the tumor is clinically staged N0 (elective neck treatment). As a consequence, large tissue volumes must be treated resulting in significant morbidity such as mucositis, dysphagia, xerostomia and on the long term also hypothyroidism and vascular damage.
If the detection of small lymph node metastases can be improved elective neck treatment may be avoided in at least part of the patients resulting in less toxicity and improved quality of life. One promising approach is the sentinel node procedure. Thus far, the sentinel node procedure is not employed in patients with larynx and pharynx cancers that are treated with primary radiotherapy. One reason is that these tumors are not easily accessible for tracer injection and this needs to be done under general anesthesia. However, in the past few years there has been progress with instrumentation via flexible endoscopy. The ENT-department of Radboudumc has developed expertise with endoscopic biopsy taking and even laser surgery of pharynx and larynx cancers.
The purpose of this study is to explore the feasibility of sentinel lymph node identification in pharynx and larynx cancers using flexible endoscopy-guided tracer injection.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged >18 years.
- •Mucosal tumor of the oropharynx, hypopharynx or larynx.
- •Patients planned to undergo biopsy via flexible endoscopy.
- •Patients planned to undergo curative radiotherapy with or without concurrent chemotherapy.
- •Patient provided written informed consent.
排除标准
- •Patients who underwent previous surgery or radiotherapy to the neck.
- •Patients with airway obstruction causing stridor.
- •Prior allergic reaction to Tc-99m-nanocolloïd.
- •Pregnancy.
- •Unable to provide informed consent.
结局指标
主要结局
Generation of SPECT-images of sufficient quality for localization of the sentinel node(s) after peritumoral Tc-99m-nanocolloid injection guided by flexible endoscopy.
时间窗: The data of each patient will be assessed within 6 months.
All SPECT images will be assessed qualitatively by concerted consensus between a nuclear medicine physician, head and neck surgeons and a radiation oncologist. Aspects that will be evaluated include: * Is there sufficient uptake of tracer for identification and localization of lymph nodes? * Does tracer uptake in primary tumor interfere with lymph node identification? * Is sentinel lymph node localization consistent with what can be expected with normal, undisturbed lymph node drainage and what is known from the literature?
次要结局
- Feasibility of administering at least 2 peritumoral Tc-99m-nanocolloid injections during one procedure of flexible endoscopy.(The data of each patient will be assesses within 6 months.)
- Comparison between sentinel nodes identified by SPECT and sentinel nodes identified by routine CT or MRI.(The data of each patient will be assesses within 6 months.)