- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04571177
PET Perfusion Imaging Techniques and Comparing Them to CT Perfusion Imaging in Stroke
April 3, 2024 updated by: University of Alberta
Developing PET Perfusion Imaging Techniques and Comparing Them to CT Perfusion Imaging in Stroke Patients
Adult patients who are diagnosed with an acute supratentorial ischemic stroke within 48 hrs of onset will be enrolled into the study.
Participants will undergo both a CT Scan and PET scan within 7 days of onset.
Participants will have the option to undergo a second PET scan with fluorodeoxyglucose (FDG).
Study Overview
Status
Active, not recruiting
Conditions
Detailed Description
Patients older than 18 years of age diagnosed with an acute supratentorial ischemic stroke within 48 hrs of symptom onset will be prospectively enrolled.
Research imaging will be obtained before 7 days after symptom onset.
The patient will receive the standardized treatment protocol at the hospital.
Informed consent will be obtained from each patient or a substitute decision maker for each individual imaging study (CTP, Rb PET, and FDG PET).
The patient will be given the option of undergoing the CTP imaging with the Rb PET only or both the Rb PET and FDG PET components.
Study Type
Observational
Enrollment (Estimated)
20
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
-
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Alberta
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Edmonton, Alberta, Canada, T6G2B7
- University of Alberta
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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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Patients who are older than 18 years of age diagnosed with an acute supratentorial ischemic stroke within 48 hrs of onset will be enrolled into the study.
Both male and female patients will be enrolled.
We want diversity among participants in order to gain insightful information about acute supratentorial ischemic stroke as possible.
A broad range in age, along with enrolling both male and female participants will allow greater diversity.
Description
Inclusion Criteria:
- Age: >18 yo
- Gender: male or female
- Acute (within 7 days from symptom onset) Supratentorial Ischemic Stroke
Exclusion Criteria:
- 1) Planned surgical intervention
- 2) Severely abnormal blood glucose level (will be excluded from FDG PET imaging)
- 3) Unable to undergo CTP or PET imaging (i.e. claustrophobia)
- 4) Pregnancy
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compare PET brain perfusion imaging to CTP
Time Frame: through study completion, 1 year from start of recruitment
|
Imaging of CTP images with the Rb PET only or both the Rb PET and FDG PET with CTP imaging components to evaluate blood flow and metabolism mismatches.
|
through study completion, 1 year from start of recruitment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Brian Buck, Associate Professor
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)
February 1, 2016
Primary Completion (Estimated)
December 31, 2024
Study Completion (Estimated)
December 31, 2025
Study Registration Dates
First Submitted
May 19, 2020
First Submitted That Met QC Criteria
September 25, 2020
First Posted (Actual)
September 30, 2020
Study Record Updates
Last Update Posted (Actual)
April 5, 2024
Last Update Submitted That Met QC Criteria
April 3, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Version 1.0 28AUG2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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