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

Sponsor
University of Avignon (Other)
Overall Status
Recruiting
CT.gov ID
NCT04605848
Collaborator
Centre Hospitalier Henri Duffaut - Avignon (Other), Assistance Publique Hopitaux De Marseille (Other)
25
1
1
44
0.6

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Infrared themrography
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
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
Actual Study Start Date :
Jul 3, 2020
Anticipated Primary Completion Date :
Nov 3, 2023
Anticipated Study Completion Date :
Mar 3, 2024

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Skin temperature in supra-clavicular region in basal condition (TSCRbasal) [Day 0]

      Skin temperature in supra-clavicular region will be recorded by infrared thermography (FLIR camera) in basal condition

    2. Skin temperature in supra-clavicular region during a cold test (TSCRcold) [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)

    3. Baseline difference in skin temperature in supra-clavicular region (diff TSCR) [Day 0]

      diff TSCR (day 0) = TSCRcold - TSCRbasal

    Secondary Outcome Measures

    1. Cutaneous blood flow in supra-clavicular region in basal condition (PUbasal) [Day 0]

      Cutaneous blood flow in supra-clavicular region will be recorded by Laser Speckle Imaging (PeriCam) in basal condition

    2. Cutaneous blood flow in supra-clavicular region during a cold test (PUcold) [Day 0]

      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)

    3. Baseline difference in cutaneous blood flow in supra-clavicular region (∆PU) [Day 0]

      diff PU (day0) =PUcold-PUbasal

    4. Volume of Brown Adipose Tissue detected by PET-CT [Day 0]

      18FDG PET-CT will be performed and volume will be segmented by PET/CT Viewer..

    5. Activity of Brown Adipose Tissue detected by PET-CT [Day 0]

      18FDG PET-CT will be performed and BAT activity (Standardized Uptake Value (SUV) will be segmented by PET/CT Viewer..

    6. Change from baseline difference in skin temperature in supra-clavicular region ( ∆ diffTSCR) at 12 months [Month 12]

      ∆ diff TSCR = diff TSCR(month12) - diff TSCR (day0)

    7. Change from baseline difference in cutaneous blood flow in supra-clavicular region ( ∆ diff PU) at 12 months [Month 12]

      ∆ diff PU = diff PU (month12) - diff PU (day0)

    8. Volume of Brown Adipose Tissue detected by PET-CT [Month 12]

      18FDG PET-CT will be performed and volume will be segmented by PET/CT Viewer..

    9. Activity of Brown Adipose Tissue detected by PET-CT [Month 12]

      18FDG PET-CT will be performed and BAT activity (Standardized Uptake Value (SUV) will be segmented by PET/CT Viewer..

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients with confirmed pheochromocytoma and/or paraganglioma
    Exclusion Criteria:
    • pregnant woman

    • breastfeeding woman

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pôle ENDO- Hopital la Conception APHM Marseille Paca France 13385

    Sponsors and Collaborators

    • University of Avignon
    • Centre Hospitalier Henri Duffaut - Avignon
    • Assistance Publique Hopitaux De Marseille

    Investigators

    • Principal Investigator: Françoise Latil-Plat, Centre Hospitalier Henri Duffaut - Avignon

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Avignon
    ClinicalTrials.gov Identifier:
    NCT04605848
    Other Study ID Numbers:
    • UAPV_180620_AVJ
    First Posted:
    Oct 28, 2020
    Last Update Posted:
    Oct 28, 2020
    Last Verified:
    Oct 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Avignon
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 28, 2020