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

Primary Purpose

Pheochromocytoma, Paraganglioma

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Infrared themrography
Sponsored by
University of Avignon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pheochromocytoma focused on measuring pheochomocytoma, brown adipose tissue, infrared thermography, cutaneous microcirculation, PET-CT

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with confirmed pheochromocytoma and/or paraganglioma

Exclusion Criteria:

  • pregnant woman
  • breastfeeding woman

Sites / Locations

  • Pôle ENDO- Hopital la Conception APHMRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BAT group

Arm Description

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-)

Outcomes

Primary Outcome Measures

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
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)
Baseline difference in skin temperature in supra-clavicular region (diff TSCR)
diff TSCR (day 0) = TSCRcold - TSCRbasal

Secondary Outcome Measures

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
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)
Baseline difference in cutaneous blood flow in supra-clavicular region (∆PU)
diff PU (day0) =PUcold-PUbasal
Volume of Brown Adipose Tissue detected by PET-CT
18FDG PET-CT will be performed and volume will be segmented by PET/CT Viewer..
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..
Change from baseline difference in skin temperature in supra-clavicular region ( ∆ diffTSCR) at 12 months
∆ diff TSCR = diff TSCR(month12) - diff TSCR (day0)
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)
Volume of Brown Adipose Tissue detected by PET-CT
18FDG PET-CT will be performed and volume will be segmented by PET/CT Viewer..
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..

Full Information

First Posted
October 8, 2020
Last Updated
November 12, 2022
Sponsor
University of Avignon
Collaborators
Centre Hospitalier Henri Duffaut - Avignon, Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT04605848
Brief Title
Infrared Thermography Associated With Cutaneous Microcirculation for Detection of Brown-adipose Tissue (MICROBAT)
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 3, 2020 (Actual)
Primary Completion Date
November 3, 2023 (Anticipated)
Study Completion Date
March 3, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Avignon
Collaborators
Centre Hospitalier Henri Duffaut - Avignon, Assistance Publique Hopitaux De Marseille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pheochromocytoma, Paraganglioma
Keywords
pheochomocytoma, brown adipose tissue, infrared thermography, cutaneous microcirculation, PET-CT

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BAT group
Arm Type
Experimental
Arm Description
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-)
Intervention Type
Diagnostic Test
Intervention Name(s)
Infrared themrography
Other Intervention Name(s)
Cutaneous microcirculation
Intervention Description
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
Primary Outcome Measure Information:
Title
Skin temperature in supra-clavicular region in basal condition (TSCRbasal)
Description
Skin temperature in supra-clavicular region will be recorded by infrared thermography (FLIR camera) in basal condition
Time Frame
Day 0
Title
Skin temperature in supra-clavicular region during a cold test (TSCRcold)
Description
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)
Time Frame
Day 0
Title
Baseline difference in skin temperature in supra-clavicular region (diff TSCR)
Description
diff TSCR (day 0) = TSCRcold - TSCRbasal
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Cutaneous blood flow in supra-clavicular region in basal condition (PUbasal)
Description
Cutaneous blood flow in supra-clavicular region will be recorded by Laser Speckle Imaging (PeriCam) in basal condition
Time Frame
Day 0
Title
Cutaneous blood flow in supra-clavicular region during a cold test (PUcold)
Description
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)
Time Frame
Day 0
Title
Baseline difference in cutaneous blood flow in supra-clavicular region (∆PU)
Description
diff PU (day0) =PUcold-PUbasal
Time Frame
Day 0
Title
Volume of Brown Adipose Tissue detected by PET-CT
Description
18FDG PET-CT will be performed and volume will be segmented by PET/CT Viewer..
Time Frame
Day 0
Title
Activity of Brown Adipose Tissue detected by PET-CT
Description
18FDG PET-CT will be performed and BAT activity (Standardized Uptake Value (SUV) will be segmented by PET/CT Viewer..
Time Frame
Day 0
Title
Change from baseline difference in skin temperature in supra-clavicular region ( ∆ diffTSCR) at 12 months
Description
∆ diff TSCR = diff TSCR(month12) - diff TSCR (day0)
Time Frame
Month 12
Title
Change from baseline difference in cutaneous blood flow in supra-clavicular region ( ∆ diff PU) at 12 months
Description
∆ diff PU = diff PU (month12) - diff PU (day0)
Time Frame
Month 12
Title
Volume of Brown Adipose Tissue detected by PET-CT
Description
18FDG PET-CT will be performed and volume will be segmented by PET/CT Viewer..
Time Frame
Month 12
Title
Activity of Brown Adipose Tissue detected by PET-CT
Description
18FDG PET-CT will be performed and BAT activity (Standardized Uptake Value (SUV) will be segmented by PET/CT Viewer..
Time Frame
Month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with confirmed pheochromocytoma and/or paraganglioma Exclusion Criteria: pregnant woman breastfeeding woman
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Agnes Vinet, PhD
Phone
33+490162931
Email
agnes.vinet@univ-avignon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Françoise Latil-Plat
Organizational Affiliation
Centre Hospitalier Henri Duffaut - Avignon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pôle ENDO- Hopital la Conception APHM
City
Marseille
State/Province
Paca
ZIP/Postal Code
13385
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent Amodru, MD

12. IPD Sharing Statement

Learn more about this trial

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

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