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

Pheochromocytoma Clinical Trial

— MICROBAT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04605848
• Other study ID #: UAPV_180620_AVJ
• Status: Terminated
• Phase: N/A
• Start date: July 3, 2020
• Est. completion date: October 20, 2023

Study information

• Verified date: May 2024
• Source: University of Avignon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: October 20, 2023
• Est. primary completion date: April 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients with confirmed pheochromocytoma and/or paraganglioma

Exclusion Criteria:

• pregnant woman
• breastfeeding woman

Related Conditions & MeSH terms

• Paraganglioma
• Pheochromocytoma

Intervention

Diagnostic Test:
• Infrared themrography
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

Locations

Country	Name	City	State
France	Pôle ENDO- Hopital la Conception APHM	Marseille	Paca

Sponsors (3)

Lead Sponsor	Collaborator
University of Avignon	Assistance Publique Hopitaux De Marseille, Centre Hospitalier Henri Duffaut - Avignon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Baseline difference in skin temperature in supra-clavicular region (diff TSCR)	diff TSCR (day 0) = TSCRcold - TSCRbasal	Day 0
Secondary	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
Secondary	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
Secondary	Baseline difference in cutaneous blood flow in supra-clavicular region (?PU)	diff PU (day0) =PUcold-PUbasal	Day 0
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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