Infrared Thermography Associated With Cutaneous Microcirculation for Detection of Brown-adipose Tissue (MICROBAT)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Pheochromocytoma, Paraganglioma

Intervention / Treatment
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* Diagnostic Test: Infrared themrography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with confirmed pheochromocytoma and/or paraganglioma Exclusion Criteria: pregnant woman breastfeeding woman

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BAT group<br>Patients will be divided in two groups for statistical analysis: patients with detectable BAT by PET-CT (BAT+) patients with no detectable BAT by PET-CT (BAT-) | Diagnostic Test: Infrared themrography<br>* measurement of 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<br>* Other names: Cutaneous microcirculation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin temperature in supra-clavicular region in basal condition (TSCRbasal) | Skin temperature in supra-clavicular region will be recorded by infrared thermography (FLIR camera) in basal condition | Day 0 | 
| Skin temperature in supra-clavicular region during a cold test (TSCRcold) | 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) | Day 0 | 
| Baseline difference in skin temperature in supra-clavicular region (diff TSCR) | diff TSCR (day 0) = TSCRcold - TSCRbasal | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cutaneous blood flow in supra-clavicular region in basal condition (PUbasal) | Cutaneous blood flow in supra-clavicular region will be recorded by Laser Speckle Imaging (PeriCam) in basal condition | Day 0 | 
| Cutaneous blood flow in supra-clavicular region during a cold test (PUcold) | Cutaneous blood flow in supra-clavicular region will be recorded by Laser Speckle Imaging (PeriCam) during a cold test (feet in water at 19°C during 20min) | Day 0 | 
| Baseline difference in cutaneous blood flow in supra-clavicular region (∆PU) | diff PU (day0) =PUcold-PUbasal | Day 0 | 
| Volume of Brown Adipose Tissue detected by PET-CT | 18FDG PET-CT will be performed and volume will be segmented by PET/CT Viewer.. | Day 0 | 
| Activity of Brown Adipose Tissue detected by PET-CT | 18FDG PET-CT will be performed and BAT activity (Standardized Uptake Value (SUV) will be segmented by PET/CT Viewer.. | Day 0 | 
| Change from baseline difference in skin temperature in supra-clavicular region ( ∆ diffTSCR) at 12 months | ∆ diff TSCR = diff TSCR(month12) - diff TSCR (day0) | Month 12 | 
| Change from baseline difference in cutaneous blood flow in supra-clavicular region ( ∆ diff PU) at 12 months | ∆ diff PU = diff PU (month12) - diff PU (day0) | Month 12 | 
| Volume of Brown Adipose Tissue detected by PET-CT | 18FDG PET-CT will be performed and volume will be segmented by PET/CT Viewer.. | Month 12 | 
| Activity of Brown Adipose Tissue detected by PET-CT | 18FDG PET-CT will be performed and BAT activity (Standardized Uptake Value (SUV) will be segmented by PET/CT Viewer.. | Month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pheochomocytoma, brown adipose tissue, infrared thermography, cutaneous microcirculation, PET-CT