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Trial registered on ANZCTR


Registration number
ACTRN12618001595202
Ethics application status
Approved
Date submitted
20/09/2018
Date registered
26/09/2018
Date last updated
26/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of neuroinflammation in boxers
Scientific title
Neuroinflammation in Boxing: Quantification of translocator protein (TSPO) expression using the tracer, [18F]-PBR111 in a PET/MRI setting.
Secondary ID [1] 296162 0
none
Universal Trial Number (UTN)
U1111-1220-7770
Trial acronym
ANIB
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neuroinflammation 309725 0
Condition category
Condition code
Neurological 308532 308532 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is an observational trial designed to estimate neuroinflammation in boxers by quantification of expression of the microglial marker, TSPO using the PET radiotracer [18F]-PBR111 as revealed in a PET/MRI brain scan.
[18F]-PBR111 binding would be analyzed in non-boxing healthy controls (baseline binding) and MS patients with demyelinating lesions (positive control).
A 5 ml venous blood sample will be obtained from participants before injection of [18F]-PBR111 for TSPO genotyping.
The bloods will be sent over to a laboratory at the QIMR Berghofer institute in batches where a simple genetic test will identify the TSPO allelic status/[18F]-PBR111 binding category of the participant i.e. either high affinity binders (HABs), mixed affinity binders (MABs) and low affinity binders (LABs).
At the initiation of the PET/MRI scan [18F]-PBR111 will be injected as a single maximum dose of 200 MBq, through an in-dwelling cannula (IDC) which will be inserted into a suitable peripheral vein, and a three way tap attached.
The injection of either tracer will be by “slow” intravenous injection over 15 seconds. This should be followed immediately by a “slow” flush of 20 ml of normal saline over a further 15 seconds.
Intervention code [1] 312466 0
Early Detection / Screening
Comparator / control treatment
[18F]-PBR111 binding would be analyzed in non-boxing healthy controls (baseline binding) who are between 20 – 50 years of age subject to identification of TSPO allelic composition which can result in either high affinity binders (HABs), mixed affinity binders (MABs) and low affinity binders (LABs).
The validity of [18F]-PBR111 to detect neuroinflammation in boxers will be assessed by measuring its uptake in active demyelinating lesions in MS patients, specifically relapsing remitting multiple sclerosis (RRMS) patients who are between 20 – 50 years of age (positive control).
Control group
Active

Outcomes
Primary outcome [1] 307509 0
Uptake of [18F]-PBR111 as assessed by PET and MRI scan
Timepoint [1] 307509 0
Following 60 min brain PET/MRI session
Secondary outcome [1] 352252 0
none
Timepoint [1] 352252 0
none

Eligibility
Key inclusion criteria
All Participants:
• Aged between 20 and 50 years (inclusive).
• Agree to participate, have capacity to consent, and are able to follow the trial instructions and procedures.
For Boxers:
• At least three years of in-ring boxing experience including training (not just drills), amateur or professional boxing.

For MS Patients:
• Diagnosis and confirmation of demyelinating lesions in the brain and symptoms of RRMS

For healthy non-boxing participants:
• Preselection of TSPO genotype from consenting individuals.
Minimum age
20 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
All Participants
• Use of benzodiazepines within one week of scanning, as these medications affect TSPO binding 1.
• Participants who are actively trying to become pregnant or who are not using an effective form of contraception (pharmacological or barrier) in the lead-up to scanning.
• Pregnancy (as demonstrated by urine test) or breastfeeding.
• Equivocal result on urine HCG may lead to deferral of scanning rather than exclusion.
• All female participants with a uterus or who have not undergone menopause that do not consent to taking a urine HCG test before the PET/MRI scan.
• History of alcohol dependence, as [18F]-PBR111 formulation contain up to 10% ethanol.
• Positive outcome on metal screening questionnaire, claustrophobia, use of anti-coagulants, history of bleeding disorder, history of kidney and liver impairment.
Boxers:
• Any reported head injury/concussion unrelated to boxing.
• Any recent infectious or inflammatory disease affecting the brain.
MS patients:
• Recent infectious or inflammatory disease other than MS.

Healthy non-boxing participants:
• Participation in any contact/combat/collision sports other than in the course of normal sporting activities during school.
• Any incidents of suspected severe head injury or concussions.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis
Based on the known allelic distribution for TSPO in human population, we estimate that initial screening of 50 healthy non-boxing healthy volunteers will yield approximately 20 HABs, 20 MABs and 4-10 LABs. Reported endpoints in the literature (DVR, VT) have variance of 10%. Given this variance, sample size calculation indicates a 73% power to detect a 10% group difference for populations of five subjects each with high or medium binding allelic status. Given the sample size calculation above, we expect significant group differences with at least five subjects per group in the contrast between HAB and MAB subjects. However, 2-3 subjects per group should be sufficient to discriminate binding results of HAB and LAB groups. Therefore, we plan to scan 5 HAB, 5 MAB and 2-3 LAB participants.
Similarly, a group of 20 boxers may yield 10 HAB, 6 MAB and 3-4 LABs. Dependent on the results of the above testing, we expect significant differences in SUV of [18F]-PBR111 in brains of the boxing group in a dose dependent manner i.e. high SUVs for boxers with higher number of bouts/year and number of years in boxing as compared to the SUV of [18F]-PBR111 in the corresponding TSPO allelic type in the non-boxing control group.
In the case of the control material, our objective is to determine the population mean signal intensity in SUV units as a function of the number of high binding alleles (zero in LABs, one in MABs, and two in HABs). This is calculated by linear regression analysis of the SUV/allele relationship in various brain regions; MANOVA will be used to determine the tracer with this highest specific signal and the 95% confidence intervals of the regression slopes will define the confidence in the group mean values of SUV as a function of allelic status.
We shall use a 1-tailed t-test to compare the mean SUV by tissue type (non-boxing versus boxer)


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/10/2018
Actual
Date of last participant enrolment
Anticipated
2/12/2019
Actual
Date of last data collection
Anticipated
2/12/2019
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 11951 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 24098 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 300717 0
Charities/Societies/Foundations
Name [1] 300717 0
The Wesley Medical Research Foundation
Country [1] 300717 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
2 George Street Brisbane QLD 4000
Country
Australia
Secondary sponsor category [1] 300264 0
None
Name [1] 300264 0
Address [1] 300264 0
Country [1] 300264 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301501 0
Royal Brisbane & Women’s Hospital Human Research Ethics Committee
Ethics committee address [1] 301501 0
Ethics committee country [1] 301501 0
Australia
Date submitted for ethics approval [1] 301501 0
26/02/2018
Approval date [1] 301501 0
23/07/2018
Ethics approval number [1] 301501 0
HREC/18/QRBW/105

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 3108 3108 0 0
/AnzctrAttachments/376038-RBWH HREC APPROVAL.pdf (Ethics approval)
Attachments [2] 3109 3109 0 0
/AnzctrAttachments/376038-PICF_boxing_version_2.4_clean_boxers_200718.pdf (Participant information/consent)
Attachments [3] 3110 3110 0 0
/AnzctrAttachments/376038-PICF_boxing_version_2.4_clean_healthycontrols_200718.pdf (Participant information/consent)
Attachments [4] 3111 3111 0 0
/AnzctrAttachments/376038-PICF_boxing_version_2.4_clean_MS patients_200718.pdf (Participant information/consent)

Contacts
Principal investigator
Name 87210 0
Prof Paul Cumming
Address 87210 0
School of Psychology and Counselling and IHBI, Queensland University of Technology, Kelvin Grove Campus, O Block – B514, Ring Road, Kelvin, Grove, QLD 4059, and QIMR Berghofer Medical Research Institute, 300 Herston Road, Brisbane QLD 4006
Country 87210 0
Australia
Phone 87210 0
+61 07 313 84757
Fax 87210 0
Email 87210 0
paul.cumming@qut.edu.au
Contact person for public queries
Name 87211 0
Omkar Patkar
Address 87211 0
School of Psychology and Counselling and IHBI, Queensland University of Technology, Kelvin Grove Campus, O Block – B514, Ring Road, Kelvin, Grove, QLD 4059, and QIMR Berghofer Medical Research Institute, 300 Herston Road, Brisbane QLD 4006
Country 87211 0
Australia
Phone 87211 0
+61 07 313 84757
Fax 87211 0
Email 87211 0
o.patkar@qut.edu.au
Contact person for scientific queries
Name 87212 0
Omkar Patkar
Address 87212 0
School of Psychology and Counselling and IHBI, Queensland University of Technology, Kelvin Grove Campus, O Block – B514, Ring Road, Kelvin, Grove, QLD 4059, and QIMR Berghofer Medical Research Institute, 300 Herston Road, Brisbane QLD 4006
Country 87212 0
Australia
Phone 87212 0
+61 07 313 84757
Fax 87212 0
Email 87212 0
o.patkar@qut.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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