Clinical trial NCT04605848: Infrared Thermography Associated With Cutaneous Microcirculation for Detection of Brown-adipose Tissue (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
Overall status: TERMINATED
Phase: NA
Conditions: Pheochromocytoma
Paraganglioma
Keywords: pheochomocytoma
brown adipose tissue
infrared thermography
cutaneous microcirculation
PET-CT
Lead sponsor: University of Avignon
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Henri Duffaut - Avignon
name: Assistance Publique Hopitaux De Marseille
First posted: 2020-10-28
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

* Patients with confirmed pheochromocytoma and/or paraganglioma

Exclusion Criteria:

* pregnant woman
* breastfeeding woman

Primary outcomes:
measure: Skin temperature in supra-clavicular region in basal condition (TSCRbasal)
timeFrame: Day 0
measure: Skin temperature in supra-clavicular region during a cold test (TSCRcold)
timeFrame: Day 0
measure: Baseline difference in skin temperature in supra-clavicular region (diff TSCR)
timeFrame: Day 0
Secondary outcomes:
measure: Cutaneous blood flow in supra-clavicular region in basal condition (PUbasal)
timeFrame: Day 0
measure: Cutaneous blood flow in supra-clavicular region during a cold test (PUcold)
timeFrame: Day 0
measure: Baseline difference in cutaneous blood flow in supra-clavicular region (∆PU)
timeFrame: Day 0
measure: Volume of Brown Adipose Tissue detected by PET-CT
timeFrame: Day 0
measure: Activity of Brown Adipose Tissue detected by PET-CT
timeFrame: Day 0
measure: Change from baseline difference in skin temperature in supra-clavicular region ( ∆ diffTSCR) at 12 months
timeFrame: Month 12
measure: Change from baseline difference in cutaneous blood flow in supra-clavicular region ( ∆ diff PU) at 12 months
timeFrame: Month 12
measure: Volume of Brown Adipose Tissue detected by PET-CT
timeFrame: Month 12
measure: Activity of Brown Adipose Tissue detected by PET-CT
timeFrame: Month 12
Other outcomes:
Locations:
city: Marseille
country: France
facility: Pôle ENDO- Hopital la Conception APHM
state: Paca
Study officials:
affiliation: Centre Hospitalier Henri Duffaut - Avignon
name: Françoise Latil-Plat
role: PRINCIPAL_INVESTIGATOR
References: