The Norepinephrine Transporter: A Novel Target for Imagin... | NCT02038595

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

NCT02038595

Sponsor

Yale University

Status

Completed

Last Update Posted

Mar 30, 2020Actual

Enrollment

10Actual

Phase

Early Phase 1

Conditions

Brown Adipose Tissue

Interventions

PET imaging

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2012

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Jan 10, 2014

First Submission Date that Met QC Criteria

Jan 14, 2014

First Posted Date

Jan 16, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 27, 2020

Last Update Posted Date

Mar 30, 2020Actual

Name	Class
NYU Langone Health	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy subjects	Experimental	Healthy subjects (male, female)	Radiation: PET imaging

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PET imaging	Radiation		Healthy subjects

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
detection of brown adipose tissue based on PET imaging		1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert Sherwin, MD	Yale University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yale University		New Haven	Connecticut	06510	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25798999	Derived	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.

ID	Term
D013057	Spectrum Analysis
D002623	Chemistry Techniques, Analytical
D008919	Investigative Techniques