Description of Brown FatBATNCT02891889
Description of the Appearance of Brown Fat in Scanner
An observational study of Description of Brown Fat, run by University Hospital, Brest at 1 site in France.
Trial summary
The aim of this study is to investigate aspects of brown fat in scanner with injection via the PET-CT study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Description of Brown Fat
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2015to Nov 2015
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients had a thoraco-abdominopelvic PET-CT examination with18F-FDG in a clinical setting which warranted.
Who may be able to join
- Consecutive patients since June 2014, who underwent a thoraco-abdominopelvic PET-CT examination with 18F-FDG in the University Hospital of Brest, in a clinical setting which warranted.
- Major Patients
- No opposition formalized
Who cannot join
- Refusal of participation
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to investigate aspects of brown fat in scanner with injection via the PET-CT study.
Read the detailed description
Brown fat is metabolically active adipose tissue. It can be responsible in PET-CT of a fixation of 18-FDG and a look of pseudo-infiltration of fat. These aspects can be sources of false positives. The objective here is to gain a better knowledge of the scanner in areas of brown fat.
- Conditions
- Description of Brown Fat
What is being measured
The primary outcome is the main question the study is designed to answer.
Density value
measured by CT and expressed in Hounsfield Units
Measured: 1 year
Secondary outcomes (1)
Standard Uptake Values (SUV) adipose tissue "white" and "brown".
SUV maximum and average
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study startNov 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Description of Brown FatStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Douraied Ben Salem, Professor, Principal investigator, CHRU de Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02891889
- Sponsor's protocol ID
- BAT
- Acronym
- BAT
- Status last verified
- Sep 2016
- First submitted
- 30 Aug 2016
- Last updated
- 8 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Description of the Appearance of Brown Fat in Scanner
- ClinicalTrials.gov ID
- NCT02891889
- Acronym / sponsor ID
- BAT / BAT
- Conditions
- Description of Brown Fat
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 8 Sep 2016 (estimated)
- 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.
The aim of this study is to investigate aspects of brown fat in scanner with injection via the PET-CT study.
Detailed description
Brown fat is metabolically active adipose tissue. It can be responsible in PET-CT of a fixation of 18-FDG and a look of pseudo-infiltration of fat. These aspects can be sources of false positives. The objective here is to gain a better knowledge of the scanner in areas of brown fat.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients had a thoraco-abdominopelvic PET-CT examination with18F-FDG in a clinical setting which warranted.
Key inclusion criteria (3 listed)
- Consecutive patients since June 2014, who underwent a thoraco-abdominopelvic PET-CT examination with 18F-FDG in the University Hospital of Brest, in a clinical setting which warranted.
- Major Patients
- No opposition formalized
Key exclusion criteria (1 listed)
- Refusal of participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Density value
Time frame: 1 year
measured by CT and expressed in Hounsfield Units
1 secondary outcome
Standard Uptake Values (SUV) adipose tissue "white" and "brown".
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2016.
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.
Douraied Ben Salem, Professor principal investigator
CHRU de Brest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Description of Brown Fat, run by University Hospital, Brest 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 8 Sep 2016. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Density value (time frame: 1 year). 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 8 Sep 2016.