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

NCT04605848 | Terminated

• 1 other identifier: UAPV_180620_AVJ
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Pheochromocytoma; Paraganglioma

Keywords

pheochomocytoma; brown adipose tissue; infrared thermography; cutaneous microcirculation; PET-CT

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• Cutaneous blood flow in supra-clavicular region in basal condition (PUbasal)

  Day 0

• Cutaneous blood flow in supra-clavicular region during a cold test (PUcold)

  Day 0

• Baseline difference in cutaneous blood flow in supra-clavicular region (∆PU)

  Day 0

• Volume of Brown Adipose Tissue detected by PET-CT

  Day 0

• Activity of Brown Adipose Tissue detected by PET-CT

  Day 0

Study Arms (1)

BAT group

EXPERIMENTAL

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

Interventions

Infrared themrography DIAGNOSTIC_TEST

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

Also known as: Cutaneous microcirculation

BAT group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with confirmed pheochromocytoma and/or paraganglioma

You may not qualify if:

• pregnant woman
• breastfeeding woman

Sponsors & Collaborators

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

Study Sites (1)

Pôle ENDO- Hopital la Conception APHM

Marseille, PACA, 13385, France

Location

MeSH Terms

Conditions

Pheochromocytoma; Paraganglioma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Study Officials

• Françoise Latil-Plat

  Centre Hospitalier Henri Duffaut - Avignon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2020
• First Posted: October 28, 2020
• Study Start: July 3, 2020
• Primary Completion: April 29, 2022
• Study Completion: October 20, 2023
• Last Updated: May 9, 2024

Record last verified: 2024-05

Locations

FR (1)