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The Norepinephrine Transporter: A Novel Target for Imaging Brown Adipose Tissue

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02038595
Recruitment Status : Completed
First Posted : January 16, 2014
Last Update Posted : March 30, 2020
Sponsor:
Collaborator:
NYU Langone Health
Information provided by (Responsible Party):
Yale University

Tracking Information
First Submitted Date  ICMJE January 10, 2014
First Posted Date  ICMJE January 16, 2014
Last Update Posted Date March 30, 2020
Study Start Date  ICMJE September 2012
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 14, 2014)		 detection of brown adipose tissue based on PET imaging [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Norepinephrine Transporter: A Novel Target for Imaging Brown Adipose Tissue
Official Title  ICMJE The Norepinephrine Transporter: A Novel Target for Imaging Brown Adipose Tissue
Brief Summary This study seeks to assess a novel imaging technique to image brown adipose tissue utilizing the norepinephrine transporter.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Brown Adipose Tissue
Intervention  ICMJE Radiation: PET imaging
Study Arms  ICMJE Experimental: Healthy subjects
Healthy subjects (male, female)
Intervention: Radiation: PET imaging
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 14, 2014)		 10
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02038595
Other Study ID Numbers  ICMJE 1008007284
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Yale University
Original Responsible Party Robert Sherwin, Yale University, Professor
Current Study Sponsor  ICMJE Yale University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE NYU Langone Health
Investigators  ICMJE
Principal Investigator: Robert Sherwin, MD Yale University
PRS Account Yale University
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP