PheochromocytomaMICROBATNCT04605848
Infrared Thermography Associated With Cutaneous Microcirculation for Detection of Brown-adipose Tissue (MICROBAT)
A study testing Infrared themrography in people with Pheochromocytoma and Paraganglioma, run by University of Avignon at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pheochromocytoma, Paraganglioma
- What is being tested?
- Infrared themrography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jul 2020to 20 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with confirmed pheochromocytoma and/or paraganglioma
Who cannot join
- pregnant woman
- breastfeeding woman
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Pheochromocytoma, Paraganglioma
- Being tested
- Infrared themrography
- Keywords
- pheochomocytoma, brown adipose tissue, infrared thermography, cutaneous microcirculation, PET-CT
- Medical subject headings
- Pheochromocytoma, Paraganglioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infrared themrographyDiagnostic test
Also called Cutaneous microcirculation
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
| Study group | Role | What they receive |
|---|---|---|
| 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-) Receives: Diagnostic Test: Infrared themrography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: Day 0
Baseline difference in skin temperature in supra-clavicular region (diff TSCR)
diff TSCR (day 0) = TSCRcold - TSCRbasal
Measured: Day 0
Secondary outcomes (9)
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
Measured: Day 0
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)
Measured: Day 0
Baseline difference in cutaneous blood flow in supra-clavicular region (∆PU)
diff PU (day0) =PUcold-PUbasal
Measured: Day 0
Volume of Brown Adipose Tissue detected by PET-CT
18FDG PET-CT will be performed and volume will be segmented by PET/CT Viewer..
Measured: Day 0
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..
Measured: Day 0
Change from baseline difference in skin temperature in supra-clavicular region ( ∆ diffTSCR) at 12 months
∆ diff TSCR = diff TSCR(month12) - diff TSCR (day0)
Measured: Month 12
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)
Measured: Month 12
Volume of Brown Adipose Tissue detected by PET-CT
18FDG PET-CT will be performed and volume will be segmented by PET/CT Viewer..
Measured: Month 12
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..
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start3 Jul 2020
- Primary completion29 Apr 2022
- Study completion20 Oct 2023
Why it stopped: recruiting problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PheochromocytomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Avignon
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Henri Duffaut - Avignon, Assistance Publique Hopitaux De Marseille
- Responsible party
- Sponsor
- Investigators
- Françoise Latil-Plat, Principal investigator, Centre Hospitalier Henri Duffaut - Avignon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04605848
- Sponsor's protocol ID
- UAPV_180620_AVJ
- Acronym
- MICROBAT
- Status last verified
- May 2024
- First submitted
- 8 Oct 2020
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04605848
- Acronym / sponsor ID
- MICROBAT / UAPV_180620_AVJ
- Conditions
- Pheochromocytoma, Paraganglioma
- Keywords
- pheochomocytoma, brown adipose tissue, infrared thermography, cutaneous microcirculation, PET-CT
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruiting problems
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of AvignonUniversity, hospital or other
- Collaborators
- Centre Hospitalier Henri Duffaut - Avignon, Assistance Publique Hopitaux De Marseille
- Study start
- 3 Jul 2020 (actual)
- Primary completion
- 29 Apr 2022 (actual)
- Study completion
- 20 Oct 2023 (actual)
- First posted
- 28 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BAT group | Experimental | Diagnostic Test: Infrared themrographyPatients 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-) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with confirmed pheochromocytoma and/or paraganglioma
Key exclusion criteria (2 listed)
- pregnant woman
- breastfeeding woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infrared themrographyAlso: Cutaneous microcirculationmeasurement 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 | Diagnostic test | BAT group |
Primary outcome
Skin temperature in supra-clavicular region in basal condition (TSCRbasal)
Time frame: Day 0
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)
Time frame: 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)
Baseline difference in skin temperature in supra-clavicular region (diff TSCR)
Time frame: Day 0
diff TSCR (day 0) = TSCRcold - TSCRbasal
9 secondary outcomes
Cutaneous blood flow in supra-clavicular region in basal condition (PUbasal)
Time frame: Day 0
Cutaneous blood flow in supra-clavicular region during a cold test (PUcold)
Time frame: Day 0
Baseline difference in cutaneous blood flow in supra-clavicular region (∆PU)
Time frame: Day 0
Volume of Brown Adipose Tissue detected by PET-CT
Time frame: Day 0
Activity of Brown Adipose Tissue detected by PET-CT
Time frame: Day 0
Change from baseline difference in skin temperature in supra-clavicular region ( ∆ diffTSCR) at 12 months
Time frame: Month 12
Change from baseline difference in cutaneous blood flow in supra-clavicular region ( ∆ diff PU) at 12 months
Time frame: Month 12
Volume of Brown Adipose Tissue detected by PET-CT
Time frame: Month 12
Activity of Brown Adipose Tissue detected by PET-CT
Time frame: Month 12
Results and safety
The study was stopped early (reason given: recruiting problems). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Françoise Latil-Plat principal investigator
Centre Hospitalier Henri Duffaut - Avignon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infrared themrography in people with Pheochromocytoma and Paraganglioma, run by University of Avignon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: recruiting problems). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin temperature in supra-clavicular region in basal condition (TSCRbasal) (time frame: Day 0). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.