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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
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Trial registered on ANZCTR
Registration number
ACTRN12625000170426
Ethics application status
Approved
Date submitted
26/11/2024
Date registered
13/02/2025
Date last updated
15/06/2025
Date data sharing statement initially provided
13/02/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Imaging Astrogliosis in Patients with Epilepsy with [18F]-FDED PET
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Scientific title
Imaging Astrogliosis with [18F]fluorodeprenyl-D2 ([18F]-FDED) PET in Patients with Drug-Resistant Epilepsy Planning Resective Epilepsy Surgery.
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Secondary ID [1]
313465
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Temporal lobe epilepsy
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Condition category
Condition code
Neurological
332453
332453
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0
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Epilepsy
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
PET imaging will be conducted at the Alfred Hospital Nuclear Medicine Department. Patients with temporal lobe epilepsy will undergo a single 60-minute dynamic PET scan with 18F-FDED (intravenous injection - 200MBq +/- 10%), prior to resective epilepsy surgery though not at any specific time point prior. Patients will also undergo MRI and EEG prior to surgery.
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Intervention code [1]
330037
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Diagnosis / Prognosis
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Comparator / control treatment
Healthy controls will undergo a single 60-minute dynamic PET scan with 18F-FDED (i.v 200MBq +/- 10%).
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Control group
Active
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Outcomes
Primary outcome [1]
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The rate of EZ localisation on 18F-FDED scans by visual read.
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Assessment method [1]
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18F-FDED scans will be visually assessed by expert physicians (epileptologists or nuclear medicine physicians) to determine whether the scans are able to localise the epileptogenic zone. This visual read will be performed in a blinded manner. Any disagreement between the two primary raters will be adjudicated by a third rater. Correct localisation will be determined by agreement with the localisation as recorded in the AER. The localisation rate will be compared to the localisation on FDG PET, MRI and EEG.
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Timepoint [1]
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Quantitative measures will be quantified immediately following PET scan. PET data (at baseline) will be compared to 12 month surgical outcome data, 12 months following surgery.
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Secondary outcome [1]
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extent of FDED uptake will be assessed.
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Assessment method [1]
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standardised uptake values and pharmacokinetic modelling will be explored to determine FDED uptake.
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Timepoint [1]
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PET data will be modelled immediately following PET scans.
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Secondary outcome [2]
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Relating 18F-FDED uptake to long term Engel Outcome following surgery.
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Assessment method [2]
443879
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Additional exploratory measures will investigate quantification of astrogliosis, through measures of standardised uptake value ratios (SUVR) and advanced pharmacokinetic modelling of 18F-FDED kinetics. For participants who proceed to resective epilepsy surgery postoperative outcome data will be obtained from the Alfred Epilepsy Registry database. The Alfred Epilepsy Registry database prospectively acquires data using RedCap surveys at prespecified timepoints (3, 6, 12, 18, 24, 36, 48, 60, and 120 months). For this study data collected from the Alfred Epilepsy Registry will be: Engel Outcome
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Timepoint [2]
443879
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Quantitative measures will be quantified immediately following PET scan. PET data will be compared to 12 month surgical outcome data, 12 months following surgery.
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Secondary outcome [3]
443880
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Relating 18F-FDED uptake to long term anxiety score.
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Assessment method [3]
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Additional exploratory measures will investigate quantification of astrogliosis, through measures of SUVR and advanced pharmacokinetic modelling of 18F-FDED kinetics. Scores Anxiety scales (collected as part of the Alfred Epilepsy Registry).
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Timepoint [3]
443880
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Quantitative measures will be quantified immediately following PET scan. PET data will be compared to 12 month surgical outcome data, 12 months following surgery.
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Secondary outcome [4]
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Relating 18F-FDED uptake to long term depression score
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Assessment method [4]
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The Alfred Epilepsy Registry database prospectively acquires data using RedCap surveys at prespecified timepoints (3, 6, 12, 18, 24, 36, 48, 60, and 120 months). For this study data collected from the Alfred Epilepsy Registry will be: Neurological Disorders Depression Inventory in Epilepsy (NDDIE)
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Timepoint [4]
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Quantitative measures will be quantified immediately following PET scan. PET data will be compared to 12 month surgical outcome data, 12 months following surgery.
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Secondary outcome [5]
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FDED uptake and anxiety score.
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Assessment method [5]
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For this study data collected from the Alfred Epilepsy Registry will be: Brief Epilepsy Anxiety Survey Instrument (BrEASI)
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Timepoint [5]
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Quantitative measures will be quantified immediately following PET scan. PET data will be compared to 12 month surgical outcome data, 12 months following surgery.
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Secondary outcome [6]
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FDED uptake and quality of life score.
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Assessment method [6]
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Quality of Life in Epilepsy 31 (QOLIE-31)
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Timepoint [6]
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Quantitative measures will be quantified immediately following PET scan. PET data (at baseline) will be compared to 12 month surgical outcome data, 12 months following surgery.
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Secondary outcome [7]
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extent of hypometabolism as determined by FDG PET
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Assessment method [7]
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standardised uptake values and pharmacokinetic modelling will be used to determine hypometabolism
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Timepoint [7]
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PET data will be modelled immediately following PET scans.
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Secondary outcome [8]
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FDED PET uptake will be compared with hypometabolism as determined by FDG PET in the epileptogenic zone to determine whether 18F-FDED provides a more specific and/or accurate delineation of the EZ.
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Assessment method [8]
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This will be performed using statistical parametric mapping (SPM) analysis.
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Timepoint [8]
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PET data will be modelled immediately following PET scans. Once modelled PET data will be compared in SPM.
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Eligibility
Key inclusion criteria
Epilepsy group:
1. Age 18-60 years
2. Clinical diagnosis of drug-resistant epilepsy (except drug responsive and healthy control groups)
3. Currently undergoing work up for resective epilepsy surgery
4. Previously completed MRI, FDG PET and video EEG for localisation of EZ and comparison with FDED-PET
5. Able to self-consent
Control group:
1. Age 18-60 years
2. Able to self-consent
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Minimum age
18
Years
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Maximum age
60
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
All participants (Epilepsy and control):
1. Pregnant or breastfeeding
2. Unstable medical condition that could impact participant safety or completion of study procedures
3. Current or recent (<3 months) cannabinoid use (either recreational or medicinal)
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
24/02/2025
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Actual
24/02/2025
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Date of last participant enrolment
Anticipated
31/12/2029
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Actual
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Date of last data collection
Anticipated
31/12/2030
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Actual
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Sample size
Target
120
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Accrual to date
11
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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The Alfred - Melbourne
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Recruitment postcode(s) [1]
43457
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3004 - Melbourne
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Australian Government Department of Industry, Sciences, and Resources
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Address [1]
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Country [1]
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Australia
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Primary sponsor type
Hospital
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Name
The Alfred
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
320247
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Address [1]
320247
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Country [1]
320247
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Alfred Hospital Ethics Committee
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Ethics committee address [1]
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https://www.alfredhealth.org.au/research/ethics-research-governance
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
316590
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Approval date [1]
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25/10/2024
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Ethics approval number [1]
316590
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Summary
Brief summary
Temporal lobe epilepsy is the most common form of focal epilepsy, and is commonly resistant to treatment with anti-seizure medications (ASMs). Successful epilepsy surgery is dependent on accurate delineation (and resection) of the epileptogenic zone (EZ). Astrocytes are a type of immune cell within the brain which are activated in response to acute injury or insult. Studies have demonstrated that activated astrocytes are present in surgically resected tissue of people with epilepsy, with other studies suggesting dysfunctional astrocytes contribute to seizure generation and propagation in drug resistant epilepsy. 18F-FDED, binds to the mono-amine oxidase B enzyme which is expressed on the surface of activated astrocytes, thus the present study will evaluate 18F-FDED PET as a technique for localising the EZ in patients with focal epilepsy.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Terence O'brien
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Address
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Alfred Centre, 99 Commercial Rd, Melbourne VIC 3004
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Country
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Australia
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Phone
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+61 418 370 566
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Fax
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Email
138342
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[email protected]
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Contact person for public queries
Name
138343
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Lucy Vivash
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Address
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Alfred Centre, 99 Commercial Rd, Melbourne VIC 3004
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Country
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Australia
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Phone
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+61430940961
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
138344
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Lucy Vivash
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Address
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Alfred Centre, 99 Commercial Rd, Melbourne VIC 3004
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Country
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Australia
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Phone
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+61430940961
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Fax
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Email
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
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only researchers who provide a methodologically sound proposal, subject to approval by research team.
Conditions for requesting access:
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-
What individual participant data might be shared?
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De-identified PET and basic demographics will be available subject to extended consent provided by participants.
What types of analyses could be done with individual participant data?
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Only to achieve the aims in the approved proposal.
When can requests for individual participant data be made (start and end dates)?
From:
Start
To:
Upon publication approx. 2030
End- No end date determined
Where can requests to access individual participant data be made, or data be obtained directly?
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Data will only be obtained from the Alfred Epilepsy Register. Registrar on call on (03) 9076 2000.
Are there extra considerations when requesting access to individual participant data?
No
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.
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