Detection of Brown Adipose Tissue by Magnetic Resonance Imaging (BAT_PET/MRI)

July 24, 2023 updated by: University of North Carolina, Chapel Hill

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

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7513
        • Recruiting
        • Biomedical Research Imaging Center
        • Contact:
        • Principal Investigator:
          • Rosa Tamara Branca, P
      • Chapel Hill, North Carolina, United States, 27599

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Healthy adult human with a BMI <28

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average dice similarity coefficient
Time Frame: Up to 1 year after the imaging scan
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

North Carolina Translational and Clinical Sciences Institute

Investigators

  • Principal Investigator: Rosa Tamara Branca, PhD, University of North Carolina, Chapel Hill

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

September 9, 2014

First Submitted That Met QC Criteria

September 9, 2014

First Posted (Estimated)

September 11, 2014

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 24, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 14-1980

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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