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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pheochromocytoma; Paraganglioma
• Intervention / Treatment: Diagnostic test: Infrared themrography

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Agnes Vinet, PhD; Phone Number: 33+490162931; Email: agnes.vinet@univ-avignon.fr

Study Locations

• France
  • Paca
    • Marseille, Paca, France, 13385
      • Recruiting
      • Pôle ENDO- Hopital la Conception APHM
      • Contact: Vincent Amodru, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with confirmed pheochromocytoma and/or paraganglioma

Exclusion Criteria:

• pregnant woman
• breastfeeding woman

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: BAT group; 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; 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; Other Names: Cutaneous microcirculation

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Avignon
• Collaborators: Assistance Publique Hopitaux De Marseille; Centre Hospitalier Henri Duffaut - Avignon
• Investigators: Principal Investigator: Françoise Latil-Plat, Centre Hospitalier Henri Duffaut - Avignon

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 3, 2020
• Primary Completion (ANTICIPATED): November 3, 2023
• Study Completion (ANTICIPATED): March 3, 2024

Study Registration Dates

• First Submitted: October 8, 2020
• First Submitted That Met QC Criteria: October 23, 2020
• First Posted (ACTUAL): October 28, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 15, 2022
• Last Update Submitted That Met QC Criteria: November 12, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: brown adipose tissue; PET-CT; infrared thermography; pheochomocytoma; cutaneous microcirculation
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Pheochromocytoma; Paraganglioma
• Other Study ID Numbers: UAPV_180620_AVJ

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No