NCT02038595

Brief Summary

This study seeks to assess a novel imaging technique to image brown adipose tissue utilizing the norepinephrine transporter.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

September 1, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 10, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 16, 2014

Completed
Last Updated

March 30, 2020

Status Verified

July 1, 2015

Enrollment Period

1.2 years

First QC Date

January 10, 2014

Last Update Submit

March 27, 2020

Conditions

Brown Adipose Tissue

Keywords

brown adipose tissue

Outcome Measures

Primary Outcomes (1)

  • detection of brown adipose tissue based on PET imaging

    1 year

Study Arms (1)

Healthy subjects

EXPERIMENTAL

Healthy subjects (male, female)

Radiation: PET imaging

Interventions

PET imagingRADIATION
Healthy subjects

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age 18-30 yrs
  • BMI \< 24 kg/m2
  • Caucasian

You may not qualify if:

  • Current neuro-psychiatric illness
  • substance abuse
  • medical or neurological illnesses likely to affect physiology or anatomy, i.e., uncontrolled hypertension, cardiovascular disorders
  • current pregnancy
  • current breast feeding
  • suicidal ideation or behavior
  • use of medications which potentially affect NET binding within 2 weeks of the PET scans.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University

New Haven, Connecticut, 06510, United States

Location

Related Publications (1)

  • Hwang JJ, Yeckel CW, Gallezot JD, Aguiar RB, Ersahin D, Gao H, Kapinos M, Nabulsi N, Huang Y, Cheng D, Carson RE, Sherwin R, Ding YS. Imaging human brown adipose tissue under room temperature conditions with (11)C-MRB, a selective norepinephrine transporter PET ligand. Metabolism. 2015 Jun;64(6):747-55. doi: 10.1016/j.metabol.2015.03.001. Epub 2015 Mar 5.

    PMID: 25798999DERIVED

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Robert Sherwin, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2014

First Posted

January 16, 2014

Study Start

September 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

March 30, 2020

Record last verified: 2015-07

Locations

US(1)