- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04171882
Microglial Cells Activation Imaging Using PET-CT With 18F-DPA714
November 21, 2021 updated by: Weibing Miao, PhD
In Vivo Assessment of Neuroinflammation With 18-FDPA714 PET/CT
There is accumulating evidence suggesting that inflammatory processes, through microglial activation, would play a key role in brain injury and degeneration.
It is considered that microglial activation would be part of self-propelling cycle of neuroinflammation that fuels Neurologic deterioration.
It is however hard to evidence microglial activation in vivo: first, the investigators need very high-resolution imaging tools and then, the only ligand available to date, 11C-PK11195, has a low sensitivity and specificity and provided heterogeneous results.
18F-DPA-714 is a new PET ligand which labels microglial cells.
The investigators aim to explore the clinical feasibility used PET-CT with 18F-DPA714 to monitor microglial cells activation of brain in several different disease.
This study might reveal significant neuroinflammatory process in the brain.
The results of this study might provide a new biomarker of disease pathological progression and help as identifying subjects who might most benefit from a specific anti-inflammatory drug.
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Anticipated)
500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: fu ying, PhD
- Phone Number: 13920263588 13920263588
- Email: fuying1995@163.com
Study Locations
-
-
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Fuzhou, China
- Recruiting
- Miu weibing
-
Contact:
- Ying Fu, PhD
- Email: fuying1995@163.com
-
Tianjin, China
- Recruiting
- Yao shaobo
-
Contact:
- Yao shaobo, PhD
- Email: yaoshaobo008@163.com
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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 to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with neurological or psychiatry diseases or known brain lesion
Description
Inclusion Criteria:
- Age > 18 years
- Positron emission tomography scans were acquired more than twice
- Written informed consent was provided by the patients and their health care proxies -
Exclusion Criteria:
- Contraindication for PET examination
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
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Standardized Uptake Value (SUV)
Time Frame: 2 years
|
Measures of specific binding of 18F-DPA-714 measures of specific binding of the tracer
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
November 1, 2019
Primary Completion (Anticipated)
November 1, 2024
Study Completion (Anticipated)
November 1, 2024
Study Registration Dates
First Submitted
November 15, 2019
First Submitted That Met QC Criteria
November 19, 2019
First Posted (Actual)
November 21, 2019
Study Record Updates
Last Update Posted (Actual)
November 23, 2021
Last Update Submitted That Met QC Criteria
November 21, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- MRCTA, ECFAH of FMU [2019]253
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.