NCT04171882

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2019

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 15, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 21, 2019

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

November 23, 2021

Status Verified

November 1, 2021

Enrollment Period

5 years

First QC Date

November 15, 2019

Last Update Submit

November 21, 2021

Conditions

Microglial Cells Activation Imaging

Outcome Measures

Primary Outcomes (1)

  • Standardized Uptake Value (SUV)

    Measures of specific binding of 18F-DPA-714 measures of specific binding of the tracer

    2 years

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with neurological or psychiatry diseases or known brain lesion

You may qualify if:

  • 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 -

You may not qualify if:

  • Contraindication for PET examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Miu weibing

Fuzhou, China

RECRUITING

Yao shaobo

Tianjin, China

RECRUITING

Central Study Contacts

fu ying, PhD

CONTACT

13920263588fuying1995@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

November 15, 2019

First Posted

November 21, 2019

Study Start

November 1, 2019

Primary Completion

November 1, 2024

Study Completion

November 1, 2024

Last Updated

November 23, 2021

Record last verified: 2021-11

Locations

CN(2)