- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05238805
Double Pet Project : A Comparison Between 11C-Acetate and 11C-acetoacetate Heart and Kidney Uptake
January 16, 2023 updated by: Université de Sherbrooke
Double Pet Project : A Comparison Between 11C-Acetate and 11C-acetoacetate Heart and
The objective of this study is to make a comparison between 11C-acetate and 11C-Acetoacetate heart and kidney metabolism
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Healthy people will have two positron emission tomography scan to perform.
One, with a 11C-Acetate Tracer and the other with 11C-Acetoacetate.
The results will allow to determine if both tracers are used in a similar way but the organs and see if the investigators can use the already validated analyse method for acetate to make acetoacetate analysis
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Quebec
-
Sherbrooke, Quebec, Canada, J1H 4C4
- Research Center on Aging
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Aged between 18 and 55
- BMI between 18,5 and 28
- Healthy
- Normal value for blood pressure
Exclusion Criteria:
- Taking drugs that could influence metabolism
- Diabetes or prediabetes
- Pregnancy or lactation
- Participation in a intensive sport program
- Being on a ketogenic diet
- Any clinical abnomally in prescreen blood sample
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Observational heart and kidney metabolism
Participants will have a PET scan with 11C-Acetate followed by a TEP Scan with 11C-Acetoacetate all in the same day.
|
Same as arm description
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean in left ventricule myocradial blood flow
Time Frame: 30 minutes
|
Heart acetate metabolism measured by TEP scan
|
30 minutes
|
|
Mean in left ventricule myocardial blood flow
Time Frame: 30 minutes
|
Heart acetoacetate metabolism measured by TEP scan
|
30 minutes
|
|
Mean in Kidney acetate uptake
Time Frame: 30 minutes
|
Kidney acetate uptake measured by TEP scan
|
30 minutes
|
|
Mean in Kidney acetoacetate uptake
Time Frame: 30 minutes
|
Kidney acetoacetate uptake measured by TEP scan.
|
30 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 14, 2022
Primary Completion (Actual)
August 14, 2022
Study Completion (Actual)
August 14, 2022
Study Registration Dates
First Submitted
January 4, 2022
First Submitted That Met QC Criteria
February 3, 2022
First Posted (Actual)
February 14, 2022
Study Record Updates
Last Update Posted (Actual)
January 18, 2023
Last Update Submitted That Met QC Criteria
January 16, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-4540
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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