A Single Case Study of Hypermetabolism

Sponsor

The Hospital for Sick Children (Other)

Overall Status

Suspended

CT.gov ID

NCT04805268

Collaborator

(none)

Enrollment

Location

Arm

35.5

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In the Metabolic Disorder clinic at The Hospital for Sick Children, the investigators identified a male, proband with possible Luft's disease. The investigators hypothesize that Luft's disease is caused by excess or dysregulation of brown/beige fat tissue.

To address the hypothesis, the investigators would like to assess brown fat distribution and activity in this subject.

Condition or Disease	Intervention/Treatment	Phase
Hypermetabolism Due to Defect in Mitochondria Luft Disease	Diagnostic Test: 18F FDG PET/CT	N/A

Detailed Description

The subject will undergo a fluorine-18-fluorodeoxyglucose positron emission tomography/computed tomography (18F FDG PET/CT) at the Diagnostic Imaging unit of The Hospital for Sick Children.

Study Design

Study Type:

Interventional

Actual Enrollment :

1 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

A Single Case Study of Hypermetabolism

Actual Study Start Date :

Dec 14, 2020

Actual Primary Completion Date :

Jan 8, 2021

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: One subject with possible Luft's disease 18F-FDG will be administered I.V., approximately 1 hour prior to PET/CT scan.	Diagnostic Test: 18F FDG PET/CT 18F FDG PET/CT imaging (fluorine-18-fluorodeoxyglucose positron emission tomography/computed tomography).

Arm

Intervention/Treatment

Experimental: One subject with possible Luft's disease

18F-FDG will be administered I.V., approximately 1 hour prior to PET/CT scan.

Diagnostic Test: 18F FDG PET/CT

18F FDG PET/CT imaging (fluorine-18-fluorodeoxyglucose positron emission tomography/computed tomography).

Outcome Measures

Primary Outcome Measures

Brown/beige fat tissue distribution and activity. Measurement tool- 18F FDG PET/CT (fluorine-18-fluorodeoxyglucose positron emission tomography/computed tomography) [1 day]
Areas of 18F-FDG uptake on PET colocalizing with regions of fat will be identified on CT (-250to -10 Hounsfield Units) and quantified by Standard Uptake Value (SUV).

Eligibility Criteria

Criteria

Ages Eligible for Study:

9 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of hypermetabolism, possible Luft's disease.

Exclusion Criteria:

None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Hospital for Sick Children	Toronto		Canada

Sponsors and Collaborators

The Hospital for Sick Children

Investigators

Principal Investigator: Andreas Schulze, MD, The Hospital for Sick Children

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Andreas Schulze, Principal Investigator, The Hospital for Sick Children

ClinicalTrials.gov Identifier:

NCT04805268

Other Study ID Numbers:

1000061502

First Posted:

Mar 18, 2021

Last Update Posted:

Jun 14, 2022

Last Verified:

Jun 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Mitochondrial Myopathies

Fluorodeoxyglucose F18

Study Results

No Results Posted as of Jun 14, 2022