Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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 information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12609000877280
Ethics application status
Approved
Date submitted
2/10/2009
Date registered
7/10/2009
Date last updated
9/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Development of Magnetic Resonance Imaging - Positron Emission Tomography (MRI-PET) Image Biomarkers for Brain Tumour Grading, Delineation and Measuring Early Treatment Response
Scientific title
Development of Magnetic Resonance Imaging - Positron Emission Tomography (MRI-PET) Image Biomarkers for Brain Tumour Grading, Delineation and Measuring Early Treatment Response
Secondary ID [1] 1108 0
nil
Universal Trial Number (UTN)
U1111-1111-0530
Trial acronym
FDOPA PET - MRI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Brain Tumour 251960 0
Condition category
Condition code
Cancer 252146 252146 0 0
Brain

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
3,4-dihydroxy-6-fluoro-phenylalanine(FDOPA) PET - MRI
Brain tumour patients will be observed from diagnosis until 12 months post treatment
Intervention code [1] 241374 0
Not applicable
Comparator / control treatment
FDOPA PET scans are not standard practice for brain tumour patients.
Standard practice is to use MRI scans to assist with diagnosis and monitor the effect of treatment.
This clinical trial will use MRI scans with the addition of FDOPA PET scans.
Historical comparisons with data stored on University of Queensland Brain Tumour MRI database (1/5/07 - 1/10/09)
Control group
Historical

Outcomes
Primary outcome [1] 253019 0
Develop new, more sensitive PET and MRI measures for detecting early treatment response.
Historical comparisons with data stored on University of Queensland Brain Tumour MRI database (1/5/07 - 1/10/09)
Timepoint [1] 253019 0
12 months after study entry.
Secondary outcome [1] 257824 0
Use advanced MRI methods and PET markers and computer analysis to determine tumour response to treatment.
Timepoint [1] 257824 0
12 monthe after study entry.

Eligibility
Key inclusion criteria
Brain tumour
Minimum age
20 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to have standard clinical practice MRI or clinical trial FDOPA PET

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2150 0
4029

Funding & Sponsors
Funding source category [1] 243834 0
Government body
Name [1] 243834 0
Smart State Innovation Fund Program
Country [1] 243834 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
The School of Information Technology and Electrical Engineering
The University of Queensland
St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 237180 0
None
Name [1] 237180 0
Address [1] 237180 0
Country [1] 237180 0
Other collaborator category [1] 886 0
Hospital
Name [1] 886 0
Royal Brisbane and Women's Hospital
Address [1] 886 0
Royal Brisbane and Women's Hospital
Butterfield St
Herston QLD 4029
Country [1] 886 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243961 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 243961 0
Royal Brisbane and Women's Hospital
Butterfield St
Herston QLD 4029
Ethics committee country [1] 243961 0
Australia
Date submitted for ethics approval [1] 243961 0
Approval date [1] 243961 0
15/04/2009
Ethics approval number [1] 243961 0
HREC/09/QRBW/18

Summary
Brief summary
Eligible patients - brain tumour
Aim - to develop new, more sensitive Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI) measures for detecting early treatment response
Treated as per standard practice with the addition of 3 3,4-dihydroxy-6-fluoro-phenylalanine (FDOPA) PET scans.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30355 0
Address 30355 0
Country 30355 0
Phone 30355 0
Fax 30355 0
Email 30355 0
Contact person for public queries
Name 13602 0
Dr Pierrick Bourgeat
Address 13602 0
UQ CCR Building 71/918
Butterfield St
Royal Brisbane and Women's Hospital
Herston QLD 4029
Country 13602 0
Australia
Phone 13602 0
+ 61 7 3253 3659
Fax 13602 0
Email 13602 0
[email protected]
Contact person for scientific queries
Name 4530 0
Prof Stuart Crozier
Address 4530 0
The School of Information Technology and Electrical Engineering
The University of Queensland
St Lucia QLD 4072
Country 4530 0
Australia
Phone 4530 0
+61 7 3365 7098
Fax 4530 0
Email 4530 0
[email protected]

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.