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

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

Study Locations

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.

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.

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