Infrared Thermography Associated With Cutaneous Microcirculation for Detection of Brown-adipose Tissue: Proof of Concept Against PET-CT in Patients Affected by Pheochomocytoma and/or Paraganglioma
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Baseline difference in skin temperature in supra-clavicular region (diff TSCR)
研究概览
简要总结
Patients affected by pheochromocytoma (PHEO) have brown-adipose tissue (BAT) hyperactivation. They perform, in routine settings, a FDG PET-CT scan. The high metabolic activity of BAT and its ability to consume both glucose and fatty acid suggest that it may have potential as a therapeutic target in the treatment of obesity. However, alternative non-invasive techniques to PET-CT BAT detection still need more validation. Accordingly, our aim will be to measure the temperature and microcirculation of the skin overlaying BAT depots in the region of FDG-uptake detected by 18F-FDG PET/CT before and after a cold test in PHEO patients.
详细描述
Objectives and Methodology:
- To analyse the change in temperature and microcirculation of the skin overlaying BAT depots in the region of FDG-uptake detected by 18F-FDG PET/CT before and after a cold test in PHEO patients.
- To check the decreased temperature and microcirculatory response after a cold test following resection of the tumor
All the patients affected by will benefit from a:
- clinical: treatments
- biological evaluations: glycemia, triglycerides, total cholesterol, HDL-C, LDL-C, plasma epinephrine and norepinephrine, urine catecholamine
- cutaneous microcirculation by means of Laser Speckle Imaging will be recorded at rest and during a cold test in the supra-clavicular region
- cutaneous microcirculation by means of Laser Doppler Flowmetry will be recorded at rest and during a cold test with one probe in the supra-clavicular region and one probe in umbilical region
- skin temperature by means of infrared thermography will be recorded at rest and during a cold test in the supra-clavicular region
Patients who will have surgery will be investigated before and after one year following resection of the tumor.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with confirmed pheochromocytoma and/or paraganglioma
排除标准
- •pregnant woman
- •breastfeeding woman
结局指标
主要结局
Baseline difference in skin temperature in supra-clavicular region (diff TSCR)
时间窗: Day 0
diff TSCR (day 0) = TSCRcold - TSCRbasal
Skin temperature in supra-clavicular region in basal condition (TSCRbasal)
时间窗: Day 0
Skin temperature in supra-clavicular region will be recorded by infrared thermography (FLIR camera) in basal condition
Skin temperature in supra-clavicular region during a cold test (TSCRcold)
时间窗: Day 0
Skin temperature in supra-clavicular region will be recorded by infrared thermography (FLIR camera) during a cold test (feet in water at 19°C during 20min)
次要结局
- Baseline difference in cutaneous blood flow in supra-clavicular region (∆PU)(Day 0)
- Change from baseline difference in skin temperature in supra-clavicular region ( ∆ diffTSCR) at 12 months(Month 12)
- Cutaneous blood flow in supra-clavicular region in basal condition (PUbasal)(Day 0)
- Volume of Brown Adipose Tissue detected by PET-CT(Month 12)
- Cutaneous blood flow in supra-clavicular region during a cold test (PUcold)(Day 0)
- Activity of Brown Adipose Tissue detected by PET-CT(Month 12)
- Change from baseline difference in cutaneous blood flow in supra-clavicular region ( ∆ diff PU) at 12 months(Month 12)