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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
13/02/2025
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
Scientific title
Imaging Astrogliosis with [18F]fluorodeprenyl-D2 ([18F]-FDED) PET in Patients with Drug-Resistant Epilepsy Planning Resective Epilepsy Surgery.
Secondary ID [1] 313465 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Temporal lobe epilepsy 335868 0
Condition category
Condition code
Neurological 332453 332453 0 0
Epilepsy

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 330037 0
Diagnosis / Prognosis
Comparator / control treatment
Healthy controls will undergo a single 60-minute dynamic PET scan with 18F-FDED (i.v 200MBq +/- 10%).
Control group
Active

Outcomes
Primary outcome [1] 339996 0
The rate of EZ localisation on 18F-FDED scans by visual read.
Timepoint [1] 339996 0
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.
Secondary outcome [1] 442245 0
extent of FDED uptake will be assessed.
Timepoint [1] 442245 0
PET data will be modelled immediately following PET scans.
Secondary outcome [2] 443879 0
Relating 18F-FDED uptake to long term Engel Outcome following surgery.
Timepoint [2] 443879 0
Quantitative measures will be quantified immediately following PET scan. PET data will be compared to 12 month surgical outcome data, 12 months following surgery.
Secondary outcome [3] 443880 0
Relating 18F-FDED uptake to long term anxiety score.
Timepoint [3] 443880 0
Quantitative measures will be quantified immediately following PET scan. PET data will be compared to 12 month surgical outcome data, 12 months following surgery.
Secondary outcome [4] 443884 0
Relating 18F-FDED uptake to long term depression score
Timepoint [4] 443884 0
Quantitative measures will be quantified immediately following PET scan. PET data will be compared to 12 month surgical outcome data, 12 months following surgery.
Secondary outcome [5] 444218 0
FDED uptake and anxiety score.
Timepoint [5] 444218 0
Quantitative measures will be quantified immediately following PET scan. PET data will be compared to 12 month surgical outcome data, 12 months following surgery.
Secondary outcome [6] 444545 0
FDED uptake and quality of life score.
Timepoint [6] 444545 0
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.
Secondary outcome [7] 444546 0
extent of hypometabolism as determined by FDG PET
Timepoint [7] 444546 0
PET data will be modelled immediately following PET scans.
Secondary outcome [8] 444547 0
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.
Timepoint [8] 444547 0
PET data will be modelled immediately following PET scans. Once modelled PET data will be compared in SPM.

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
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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)

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
24/02/2025
Actual
Date of last participant enrolment
Anticipated
31/12/2029
Actual
Date of last data collection
Anticipated
31/12/2030
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 27364 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 43457 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 317902 0
Government body
Name [1] 317902 0
Australian Government Department of Industry, Sciences, and Resources
Country [1] 317902 0
Australia
Primary sponsor type
Hospital
Name
The Alfred
Address
Country
Australia
Secondary sponsor category [1] 320247 0
None
Name [1] 320247 0
Address [1] 320247 0
Country [1] 320247 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316590 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 316590 0
Ethics committee country [1] 316590 0
Australia
Date submitted for ethics approval [1] 316590 0
Approval date [1] 316590 0
25/10/2024
Ethics approval number [1] 316590 0

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

Contacts
Principal investigator
Name 138342 0
Prof Terence O'brien
Address 138342 0
Alfred Centre, 99 Commercial Rd, Melbourne VIC 3004
Country 138342 0
Australia
Phone 138342 0
+61 418 370 566
Fax 138342 0
Email 138342 0
te.obrien@alfred.org.au
Contact person for public queries
Name 138343 0
Lucy Vivash
Address 138343 0
Alfred Centre, 99 Commercial Rd, Melbourne VIC 3004
Country 138343 0
Australia
Phone 138343 0
+61430940961
Fax 138343 0
Email 138343 0
lucy.vivash@monash.edu
Contact person for scientific queries
Name 138344 0
Lucy Vivash
Address 138344 0
Alfred Centre, 99 Commercial Rd, Melbourne VIC 3004
Country 138344 0
Australia
Phone 138344 0
+61430940961
Fax 138344 0
Email 138344 0
lucy.vivash@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified PET and basic demographics will be available subject to extended consent provided by participants.
When will data be available (start and end dates)?
Start - Upon publication approx. 2030
End- No end date determined
Available to whom?
only researchers who provide a methodologically sound proposal, subject to approval by research team.
Available for what types of analyses?
Only to achieve the aims in the approved proposal.
How or where can data be obtained?
Data will only be obtained from the Alfred Epilepsy Register. Registrar on call on (03) 9076 2000.


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.