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Application of a novel neuroinflammatory positron tracer [¹8F]FPyCB-1 in migraine

Application of a novel neuroinflammatory positron tracer [¹8F]FPyCB-1 in migraine

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600121094
Enrollment
Unknown
Registered
2026-03-25
Start date
2026-04-06
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

episodic migraine and Chronic migraine

Interventions

Sponsors

The First Medical Centre, Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 70 Years

Inclusion criteria

Inclusion criteria: Aged 30–70 years (including the boundary values), right-handed, meeting the classification criteria for migraine according to the International Classification of Headache Disorders, 3rd edition (ICHD-3) [7], the enrollment criteria for each group are as follows: 1.Inclusion criteria for episodic migraine: (1) Meets the diagnostic criteria for episodic migraine as defined in the Third International Classification of Headache Disorders (ICHD-3): (2) Has experienced less than 15 migraine attacks per month in the past 3 months, and has had at least 2 but no more than 8 migraine attacks per month. 2. chronic migraine inclusion criteria: (1) Meet the diagnostic criteria for chronic migraine in the third edition of the International Classification of Headaches (ICHD-3): (2) Presented with headaches for more than 15 days per month, lasting for 3 months or more, and having at least 8 headache days per month that meet the characteristics of migraine; (3) At least 5 headaches meeting criteria B-D of 1.1 migraine without aura and/or criteria B and C of 1.2 migraine with aura; (4) The main features are unilateral or bilateral alternating attacks, moderate to severe, throbbing headaches, and exacerbation after exertion, usually lasting 4 to 72 hours, and may be accompanied by photophobia, phonophobia, nausea, and vomiting; 3. The inclusion criteria for the healthy control group include: (1) The overall physical condition is healthy; (2) Age, gender and experimental group patients matched.

Exclusion criteria

Exclusion criteria: 1. History of any primary, secondary, or other headaches besides migraine; healthy control group: history of any primary, secondary, or other headaches, with a family history related to headaches; 2. CM group patients: use of nonsteroidal anti-inflammatory drugs (NSAIDs), CGRP monoclonal antibodies, CGRP receptor antibodies, and triptans within 2 weeks prior to scanning; preventive migraine medication (including ß-blockers, antiepileptic drugs, antidepressants, and flunarizine hydrochloride) within 4 weeks prior to scanning; undergoing PET/MR scan during a migraine attack. 3. Unwilling to cooperate to complete all examination items and related scale assessments of the study; 4. Allergic to the experimental drug or any of its components and/or have a history of severe allergic reactions to drugs or allergens; 5. History of stroke, HIS > 4 points; 6. History of alcohol or drug abuse/dependence; 7. Major psychiatric disorders: including anxiety disorders, affective disorders, severe psychosis, or drug-induced psychosis; 8. Neurological diseases: including brain tumors, traumatic brain injury, multiple sclerosis, epilepsy, etc.; 9. Severe internal diseases; currently using respiratory medications, cardiovascular drugs, anticonvulsants, or psychoactive substances; 10. Patients unwilling to sign the informed consent form.

Design outcomes

Primary

MeasureTime frame
Regional distribution characteristics in the brain;Degree of sedimentation;

Countries

China

Contacts

Public ContactRuozhuo Liu

The First Medical Centre, Chinese PLA General Hospital

liurz301@163.com+86 139 1088 0017

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 4, 2026