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

NCT ID: NCT04605848

Last Updated: 2024-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-03

Study Completion Date

2023-10-20

Brief Summary

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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

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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.

Conditions

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Pheochromocytoma Paraganglioma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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-)

Group Type EXPERIMENTAL

Infrared themrography

Intervention Type 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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Cutaneous microcirculation

Eligibility Criteria

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Inclusion Criteria

* Patients with confirmed pheochromocytoma and/or paraganglioma

Exclusion Criteria

* pregnant woman
* breastfeeding woman
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Henri Duffaut - Avignon

OTHER

Sponsor Role collaborator

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role collaborator

University of Avignon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Françoise Latil-Plat

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Henri Duffaut - Avignon

Locations

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Pôle ENDO- Hopital la Conception APHM

Marseille, PACA, France

Site Status

Countries

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France

Other Identifiers

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UAPV_180620_AVJ

Identifier Type: -

Identifier Source: org_study_id

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