Chroinc PainNCT06701734
Targeted Translocator Protein PET Imaging Evaluate Neuroinflammation of the Chronic Pain Patients
An observational study of Chroinc Pain and PET, run by Weibing Miao, PhD.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chroinc Pain, PET, Microglial Activation
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with chronic pain
Who may be able to join
- chronic pain patients
- Written informed consent was provided by the patients and their family
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Chroinc Pain, PET, Microglial Activation
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized Uptake Value
Measures of specific binding of 18F-DPA-714 measures of specific binding of the tracer
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start1 Dec 2024 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chroinc PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weibing Miao, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Weibing Miao, PhD, First Affiliated Hospital of Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06701734
- Sponsor's protocol ID
- Chronic_pain_DPA714 PET
- Status last verified
- Nov 2024
- First submitted
- 16 Nov 2024
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Translocator Protein PET Imaging Evaluate Neuroinflammation of the Chronic Pain Patients
- ClinicalTrials.gov ID
- NCT06701734
- Acronym / sponsor ID
- Chronic_pain_DPA714 PET
- Conditions
- Chroinc Pain, PET, Microglial Activation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Weibing Miao, PhDUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 22 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic pain
Key inclusion criteria (2 listed)
- chronic pain patients
- Written informed consent was provided by the patients and their family
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Standardized Uptake Value
Time frame: 2 years
Measures of specific binding of 18F-DPA-714 measures of specific binding of the tracer
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Chroinc Pain and PET, run by Weibing Miao, PhD.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qianqian Xue (+8618558799064, xueqian124@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standardized Uptake Value (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.