n/a
Conditions
Interventions
Product Name: [11C]-PK11195
Product Code: [11C]-PK11195
Pharmaceutical Form: Injection
INN or Proposed INN: [11C]-PK11195
CAS Number: n/a
Current Sponsor code: [11C]-PK11195
Other descriptive name: [1
Sponsors
University Medical Center Groningen
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: All subjects: -Age above 18 and below 50 years -Male sex -Written informed consent for participation Boxers only: -Minimum amount of 20 competitive bouts in Muay Thai boxing with rank A or B -Minimum amount of 3 training sessions per week Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: All subjects: -The use of benzodiazepines. -The use of anticoagulants or having coagulation disorder. -Use of somatic medication that may affect the immune system. -Use of any investigational drug. -Current or recent (<1 year) alcohol or substance abuse. -Current or recent (<4 weeks) infectious or inflammatory disease. -Current systemic disease. -Major metabolic disease. -Somatic, organic or neurological disorder (other than mTBI for patients). -Participation in a scientific research study (<1 year) involving radiation. -Claustrophobia. -Presence of materials in the body that can be magnetized. -Sustained (mild) traumatic brain injury within last 3 months. For healthy volunteers only: -Presence of infection of inflammation. -(History of) Participation in contact sports, such as boxing, Muay Thai boxing, rugby, American football, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to determine whether neuroinflammation is present in subjects who have been exposed to chronic repetitive head injury during Muay Thai boxing, using [11C]-PK11195 PET. ;Secondary Objective: Secondary objectives are to determine if there is a correlation between [11C]-PK11195 binding and: (1) the degree of cognitive deficits, as measured by neuropsychological tests, (2) white matter integrity, as measured by DTI, (3) regional cerebral blood flow as measured by ASL-MRI, and (4) serum proteins indicative of inflammation (e.g. C-reactive protein, IL-6).;Primary end point(s): n/a;Timepoint(s) of evaluation of this end point: n/a | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): n/a;Timepoint(s) of evaluation of this end point: n/a | — |
Countries
Netherlands
Contacts
Public ContactClinical Trial Information
University Medical Center Groningen
Outcome results
None listed