Back to resultsA Single Case Study of Hypermetabolism
Primary Purpose
Hypermetabolism Due to Defect in Mitochondria, Luft Disease
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
18F FDG PET/CT
Sponsored by
About this trial
This is an interventional diagnostic trial for Hypermetabolism Due to Defect in Mitochondria
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of hypermetabolism, possible Luft's disease.
Exclusion Criteria:
- None
Sites / Locations
- The Hospital for Sick Children
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
One subject with possible Luft's disease
Arm Description
18F-FDG will be administered I.V., approximately 1 hour prior to PET/CT scan.
Outcomes
Primary Outcome Measures
Brown/beige fat tissue distribution and activity. Measurement tool- 18F FDG PET/CT (fluorine-18-fluorodeoxyglucose positron emission tomography/computed tomography)
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT04805268
First Posted
March 3, 2021
Last Updated
December 21, 2022
Sponsor
The Hospital for Sick Children
1. Study Identification
Unique Protocol Identification Number
NCT04805268
Brief Title
A Single Case Study of Hypermetabolism
Official Title
A Single Case Study of Hypermetabolism
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
December 14, 2020 (Actual)
Primary Completion Date
January 8, 2021 (Actual)
Study Completion Date
December 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypermetabolism Due to Defect in Mitochondria, Luft Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
One subject with possible Luft's disease
Arm Type
Experimental
Arm Description
18F-FDG will be administered I.V., approximately 1 hour prior to PET/CT scan.
Intervention Type
Diagnostic Test
Intervention Name(s)
18F FDG PET/CT
Intervention Description
18F FDG PET/CT imaging (fluorine-18-fluorodeoxyglucose positron emission tomography/computed tomography).
Primary Outcome Measure Information:
Title
Brown/beige fat tissue distribution and activity. Measurement tool- 18F FDG PET/CT (fluorine-18-fluorodeoxyglucose positron emission tomography/computed tomography)
Description
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).
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of hypermetabolism, possible Luft's disease.
Exclusion Criteria:
None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Schulze, MD
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
Country
Canada
12. IPD Sharing Statement
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A Single Case Study of Hypermetabolism
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