Study of the Relationship Between Clinical, Imaging and Biological Data in Patients With Squamous Cell Carcinoma of the Tongue
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- variation in the metabolite TMA-Cho (trimethylamine-choline), between healthy subjects and patients before surgery
研究概览
简要总结
Squamous cell carcinoma (SCC) could be a very aggressive cancer and has a bad prognosis if not detected early and thus is associated with high mortality. The development of simple and reliable biomarkers for the early detection of SCC is one of the solutions to better diagnose, treat these tumors, evaluate and monitor treatments, and hence reduce mortality. In a previous work, the investigators demonstrated the ability of Proton Magnetic resonance spectroscopy (1H-MRS) to non-invasively assess spectroscopic and metabolic profiles of tongue tissue in healthy subjects. In the present work, the investigators challenge the use of in-vivo 1H-MRS as a potential method for non-invasive metabolic monitoring of patients with squamous cell carcinoma of the tongue undergoing therapy. Thus the main objective is to study the spectroscopic and metabolic differences, e.g. including variation in the metabolite TMA-Cho (trimethylamine-choline), of tongue tissue between healthy subjects and in patients with squamous cell carcinoma of the tongue, before and after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients from the maxillofacial surgery department of the Amiens-Picardie University Hospital treated for histologically confirmed squamous cell carcinoma of the tongue
- •Patients who have not yet been treated, either surgically or by neoadjuvant treatment
- •Patients with a tumor of minimum dimensions of 15 mm in long axis
- •Patients without contraindication to MRI
- •Patients over 18 years old
- •Patients who have provided free and informed written consent
- •Patients benefiting from a social security system
- •Healthy volunteers:
- •Subjects without a history of cancer of the upper aerodigestive tract
- •Subjects without contraindication to MRI
- •Subjects over 18 years old
- •Subjects who have provided free and informed written consent
- •Subjects benefiting from a social security system
排除标准
- •Patients:
- •Patients with a lingual tumor measuring less than 15 mm in long axis
- •Patients and healthy volunteers:
- •Patients with other histological types of cancer, or other locations
- •Subjects with a contraindication to MRI
- •Subjects under 18 years old
- •Pregnant or breastfeeding women
- •Persons under guardianship, curators, protection of justice or deprived of liberty
结局指标
主要结局
variation in the metabolite TMA-Cho (trimethylamine-choline), between healthy subjects and patients before surgery
时间窗: day 1
variation in the metabolite TMA-Cho (trimethylamine-choline), between healthy subjects and patients after surgery
时间窗: day 1
次要结局
- The variation of lipid contents in the tongue tissue between healthy subjects and patients before surgery(day 1)
- The variation of lipid contents in the tongue tissue between healthy subjects and patients after surgery(day 1)