Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000445471
Ethics application status
Approved
Date submitted
24/08/2007
Date registered
31/08/2007
Date last updated
20/11/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Investigation of the role of functional imaging predicting the relapse patterns of high grade gliomas
Scientific title
A Single Group Study to Investigate the Functional Role of Imaging Using a Thallium Single Photon Emission Computed Tomography "SPECT" scan of the Brain to Predict Relapse In Patients with High Grade Gliomas
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
high grade gliomas 2291 0
cancer 2292 0
Condition category
Condition code
Cancer 2388 2388 0 0
Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A Thallium Single Photon Emission Computed Tomography "SPECT" Scan of the Brain will be performed at 3 time points, pre treatment, 3 months post treatment and at the time of recurrence. This scan takes one hour to perform.
Intervention code [1] 2006 0
Diagnosis / Prognosis
Comparator / control treatment
not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3289 0
site of recurrence
Timepoint [1] 3289 0
brain SPECT scan performed at 3 months then followed with routine MRI's. On recurrence another SPECT scan is performed
Secondary outcome [1] 5469 0
survival
Timepoint [1] 5469 0
Patients will be followed 3 monthly till death

Eligibility
Key inclusion criteria
high grade gliomas (WHO III or IV)
intended treatment is for radical radiation
available for follow up
written consent
Minimum age
18 Years
Maximum age
N/A
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
intended for palliative radiation only

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
Single group
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
14/09/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2547 0
Self funded/Unfunded
Name [1] 2547 0
na
Country [1] 2547 0
Australia
Primary sponsor type
Individual
Name
Dr Thomas Eade
Address
Radiation Oncology
Royal North Shore Hospital
St Leonards NSW 2065
Country
Australia
Secondary sponsor category [1] 2306 0
None
Name [1] 2306 0
Address [1] 2306 0
Country [1] 2306 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4473 0
NSCCAHS HREC
Ethics committee address [1] 4473 0
Ethics committee country [1] 4473 0
Australia
Date submitted for ethics approval [1] 4473 0
Approval date [1] 4473 0
14/09/2006
Ethics approval number [1] 4473 0
0607-120M

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

Contacts
Principal investigator
Name 28002 0
Address 28002 0
Country 28002 0
Phone 28002 0
Fax 28002 0
Email 28002 0
Contact person for public queries
Name 11159 0
Dr Thomas Eade
Address 11159 0
Radiation Oncology
RNSH
St Leonards NSW 2065
Country 11159 0
Australia
Phone 11159 0
02 9926-5010
Fax 11159 0
Email 11159 0
teade@nsccahs.health.nsw.gov.au
Contact person for scientific queries
Name 2087 0
Dr Thomas Eade
Address 2087 0
Radiation Oncology
RNSH
St Leonards NSW 2065
Country 2087 0
Australia
Phone 2087 0
02 9926-5010
Fax 2087 0
Email 2087 0
teade@nsccahs.health.nsw.gov.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

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

Documents added automatically
No additional documents have been identified.