Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000721303
Ethics application status
Approved
Date submitted
12/05/2017
Date registered
18/05/2017
Date last updated
18/05/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Identifying Neuroimaging Markers of Neuroinflammation in Neurodegenerative Diseases
Scientific title
Identifying in vivo markers of neuroinflammation in neurodegenerative diseases using simultaneous Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI)
Secondary ID [1] 291913 0
None
Universal Trial Number (UTN)
U1111-1196-5110
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Huntington's Disease 303231 0
Condition category
Condition code
Neurological 302659 302659 0 0
Neurodegenerative diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Positron Emission Tomography (PET):
- Intravenous injection, via forearm cannula, of 250MBq of 18F-FEMPA PET tracer by a qualified nuclear medicine technologist on a single occasion in a University medical imaging research facility.
- 60min recording, from time of injection, of PET data from the whole brain using a Siemens Biograph PET/MR commercial scanner, operated by a qualified nuclear medicine technologist and MR radiographer.

Magnetic Resonance Imaging (MRI):
- Noninvasive acquisition of anatomical, diffusion, perfusion, spectroscopic, and functional MRI data over 60mins, simultaneous to the PET acquisitions using a Siemens Biograph MR/PET commercial scanner, operated by a qualified MR radiographer.

Study procedures will be the same across all participants.
Intervention code [1] 298035 0
Not applicable
Comparator / control treatment
(i) Patient groups will be compared against healthy individuals with no diagnosed neurodegenerative illness; (ii) Symptomatic HD will be compared against pre-symptomatic individuals who are gene-positive for HD
Control group
Active

Outcomes
Primary outcome [1] 302062 0
Standardised uptake value, normalised to the whole brain (SUVR), of 18F-FEMPA at all points in the brain in the patient cohort relative to the healthy control cohort.
Timepoint [1] 302062 0
Single timepoint
Secondary outcome [1] 334666 0
Relationship between 18F-FEMPA SUVR and a structural MR-derived measure of brain volume at all points in the brain in the patient cohort.
Timepoint [1] 334666 0
Single Timepoint
Secondary outcome [2] 334832 0
Relationship between 18F-FEMPA SUVR and a MR-spectroscopy derived measure of edema in the striatum and frontal cortex (as a composite) in the patient cohort.
Timepoint [2] 334832 0
Single Timepoint
Secondary outcome [3] 334833 0
Relationship between 18F-FEMPA SUVR and a diffusion MR-derived measure of axonal integrity at all points in the white matter of the brain in the patient cohort.
Timepoint [3] 334833 0
Singe Timepoint

Eligibility
Key inclusion criteria
Symptomatic Huntington's Disease (HD) Cohort:
- Adults with genetically-confirmed HD with clinical confirmation of frank motor symptoms

Presymptomatic HD cohort:
- Adults with genetically-confirmed HD with clinical confirmation of ABSENT motor symptoms

Healthy Control Cohorts:
- Adults statistically matched for age and gender to the patient cohorts
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Inflammatory or auto-immune conditions
- Current use of anti-inflammatory medications (including NSAIDs and Steroids)
- Neurological disorders (excepting HD in the HD cohorts), including dementia
- History of head injury requiring medical follow-up
- MRI contra-indications (e.g., MR-incompatible implants)
- Pregnant or Breast-Feeding Females

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis
Sample sizes were determined based on comparable studies undertaken in similar cohorts, and current standards employed in observational neuroimaging research.

Standardised uptake values, normalised to the whole brain, of the PET tracer will be calculated at every point (voxel) in the brain for each participant. Group comparisons (patients versus controls) will be undertaken using non-parametric inference with cluster-level correction for multiple comparisons across the brain.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2017
Actual
Date of last participant enrolment
Anticipated
1/08/2019
Actual
Date of last data collection
Anticipated
1/08/2019
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 15963 0
3800 - Monash University

Funding & Sponsors
Funding source category [1] 296418 0
University
Name [1] 296418 0
Monash University, Faculty of Medicine Nursing and Health Sciences
Country [1] 296418 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Monash Institute of Cognitive and Clinical Neurosciences
18 Innovation Walk, Clayton Campus
Monash University
Clayton Victoria 3800
Australia
Country
Australia
Secondary sponsor category [1] 295364 0
None
Name [1] 295364 0
Address [1] 295364 0
Country [1] 295364 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297644 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 297644 0
Ethics committee country [1] 297644 0
Australia
Date submitted for ethics approval [1] 297644 0
01/03/2017
Approval date [1] 297644 0
11/04/2017
Ethics approval number [1] 297644 0
2017-7810

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74690 0
Dr Ian Harding
Address 74690 0
Monash Institute of Cognitive and Clinical Neurosciences
18 Innovation Walk, Clayton Campus
Monash University
Victoria 3800
Country 74690 0
Australia
Phone 74690 0
+61 3 9905 9283
Fax 74690 0
Email 74690 0
ian.harding@monash.edu
Contact person for public queries
Name 74691 0
Ian Harding
Address 74691 0
Monash Institute of Cognitive and Clinical Neurosciences
18 Innovation Walk, Clayton Campus
Monash University
Victoria 3800
Country 74691 0
Australia
Phone 74691 0
+61 3 9905 9283
Fax 74691 0
Email 74691 0
ian.harding@monash.edu
Contact person for scientific queries
Name 74692 0
Ian Harding
Address 74692 0
Monash Institute of Cognitive and Clinical Neurosciences
18 Innovation Walk, Clayton Campus
Monash University
Victoria 3800
Country 74692 0
Australia
Phone 74692 0
+61 3 9905 9283
Fax 74692 0
Email 74692 0
ian.harding@monash.edu

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.