NCT06701734

Brief Summary

Chronic pain is a major public health issue, which seriously affects patients' quality of life. Neuroinflammation is an important mechanism resulting in chronic pain. Translocator protein (TSPO) has served as a marker of microglial activation and neuroinflammation. 18F-DPA714, a tracer targeted TSPO, can be used to evaluate the microglial activation and neuroinflammation in vivo by PET imaging.Recent and increasing studies have found changes in TSPO and its ligands in various chronic pain models. Reversing their expressions has been shown to alleviate chronic pain in these models, illustrating the effects of TSPO and its ligands.The investigators aim to explore the clinical feasibility used 18F-DPA714 PET imaging to monitor microglial cells activation of center nervous system in chronic pain patients. This study might reveal significant neuroinflammatory process in the center nervous system of the chronic pain patients. The results of this study might provide a new biomarker of disease pathological progression and indicates that TSPO-based therapy may become an alternative strategy for treating chronic pain.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
33mo left

Started Dec 2024

Longer than P75 for all trials

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress35%
Dec 2024Dec 2028

First Submitted

Initial submission to the registry

November 16, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 22, 2024

Completed
9 days until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

November 22, 2024

Status Verified

November 1, 2024

Enrollment Period

4.1 years

First QC Date

November 16, 2024

Last Update Submit

November 20, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Standardized Uptake Value

    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 chronic pain

You may qualify if:

  • chronic pain patients
  • Written informed consent was provided by the patients and their family

You may not qualify if:

  • history of head trauma , epilepsy, claustrophobia, rheumatic or autoimmune diseases, psychiatric disorders, severe somatic diseases (neurological,cardiovascular, etc.),previous heart or brain surgery, substance abuse, inability to refrain from hypnotics, magnetic implants, pregnancy, lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

blood

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

November 16, 2024

First Posted

November 22, 2024

Study Start

December 1, 2024

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

November 22, 2024

Record last verified: 2024-11