NCT02237872

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-glucose (fluorodeoxyglucose) -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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2015

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 11, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

January 20, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 27, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 27, 2015

Completed
Last Updated

October 1, 2025

Status Verified

August 1, 2025

Enrollment Period

7 months

First QC Date

September 9, 2014

Last Update Submit

September 25, 2025

Conditions

Keywords

Brown Adipose TissueMRI and PET detection of brown adipose tissue

Outcome Measures

Primary Outcomes (1)

  • Average dice similarity coefficient

    The average dice similarity coefficient will be measured to assess the overlap between MRI and PET maps

    Up to 1 year after the imaging scan

Study Arms (1)

Healthy Volunteers

Healthy volunteers exposed to cold to activate brown fat

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy adult human with a BMI \<28

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Biomedical Research Imaging Center

Chapel Hill, North Carolina, 27599-7513, United States

Location

Biomedical Research Imaging Center

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Rosa Tamara Branca, PhD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2014

First Posted

September 11, 2014

Study Start

January 20, 2015

Primary Completion

August 27, 2015

Study Completion

August 27, 2015

Last Updated

October 1, 2025

Record last verified: 2025-08

Locations