Clinical trial NCT02237872: Detection of Brown Adipose Tissue by Magnetic Resonance Imaging
Official title: Assessment of MRI Accuracy for the Detection of Brown Adipose Tissue Using 18F-2-fluoro-2-deoxy-D-glucose Fluorodeoxyglucose -PET as a Gold Standard
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity
Keywords: Brown Adipose Tissue
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: North Carolina Translational and Clinical Sciences Institute
First posted: 2014-09-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy adult human with a BMI \<28

Brief summary: The primary goal of this study is to assess the accuracy of conventional fat fraction proton MRI for the detection of Brown Adipose Tissue (BAT) in healthy subjects using 18F-2-fluoro-2-deoxy-D-glucosefluorodeoxyglucose -PET as gold standard.

In this pilot study, MRI and PET imaging of BAT of healthy adult volunteers will be performed on a combined PET/MRI scanner under mild cold condition.

Detailed description: In the fight against obesity, brown adipose tissue (BAT) is considered to be the newest target. The hypothesis is that this tissue is partially responsible for the imbalance between energy intake and energy expenditure that keeps lean people lean and obese people obese.

The detection of this tissue in adult humans represents an unmet need. BAT is difficult to detect and measurements of tissue fat fraction performed by magnetic resonance imaging have been proposed as a mean to differentiate the highly hydrated brown fat from the less hydrated white adipose tissue and from muscle.

To this end, the objective of this study is to assess the accuracy of magnetic resonance fat fraction measurements for the detection of BAT volume in adult humans, while using PET with 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose as gold standard.

For this study subjects will undergo a combined MRI/PET scan. The scans will be done during stimulation of thermogenic activity by mild cold exposure.

Eligibility criteria: Inclusion Criteria:

* Each subject must be fully informed and have signed consent.
* BMI \< 34
* Normal neurological and psychological development / able to give consent
* Willingness to participate in this study

Exclusion Criteria:

* Subjects less than 18 years of age
* Severe claustrophobia
* Women who are pregnant, nursing an infant or planning to become pregnant in the next 30 days
* People who have a condition that makes MRI unsafe for them (for example, cardiac pacemaker, epicardial pacemaker leads, cochlear implants, metal aneurysm clip, iron filings in your eyes or metal halo devices)
* Have had radiation therapy or chemotherapy in the 2 months prior to PET scan
* Subjects are taking medications that may interfere with BAT detection

Primary outcomes:
measure: Average dice similarity coefficient
timeFrame: Up to 1 year after the imaging scan
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Biomedical Research Imaging Center
state: North Carolina
city: Chapel Hill
country: United States
facility: Biomedical Research Imaging Center
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Rosa Tamara Branca, PhD
role: PRINCIPAL_INVESTIGATOR
References: