Trial Review

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
ACTRN12610000389000
Ethics application status
Approved
Date submitted
30/04/2010
Date registered
13/05/2010
Date last updated
12/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Positron Emission Tomography (PET) scans in suspected residual or recurrent brain tumours.
Scientific title
The feasibility and preliminary clinical utility of 11C-Methionine and 18F-Fluorothymidine Positron Emission Tomography-Computerised Tomography (PET-CT) imaging following radiotherapy and 2-3 cycles of adjuvant chemotherapy in patients with high grade glioma in order to assess time to progression, overall survival and 6 month progression-free survival.
Secondary ID [1] 251760 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glioma 257270 0
Condition category
Condition code
Cancer 257418 257418 0 0
Brain

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
11C-Methionine (C-MET) and 18F-Fluorothymidine (FLT) imaging will be performed on all consenting eligible patients receiving adjuvant temozolomide containing chemotherapy, at the same time as their routine mid-treatment Magnetic Resonance Imaging (MRI) scan. Current routine care at our institution involves an MRI following 3 cycles of adjuvant temozolamide chemotherapy. Several clinical trials are however commencing which require an MRI after 2 cycles of temozolamide chemotherapy and thus the protocol will allow the C-MET and FLT PET-CT scans to coincide with the patient’s planned MRI scan which will be performed either after cycle 2 or 3 of adjuvant chemotherapy. A cycle is defined as temozolomide administered days 1-5 every 28 days. Patients who are not treated in this way will not be eligible. Information on the number of cycles will be obtained from the treating medical oncologist; start dates of each cycle will be recorded.
For the C-MET PET-CT scan intravenous dose administered will be 300 MBq/m2 according to patient body surface area (BSA). For the FLT PET-CT scan intravenous dose administered will be 100 MBq/m2 according to patient BSA
Intervention code [1] 256389 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258334 0
Time to progression with progression as defined by MacDonald criteria
Timepoint [1] 258334 0
Measured both from date of diagnosis (ie: date of original pathological diagnosis) and from date of post cycle 2 or 3 MRI.
Primary outcome [2] 258335 0
Overall survival. Patients will be followed clinically to determine outcome. Survival will be measured both from date of diagnosis (ie: date of original pathological diagnosis) and from date of post cycle 2 or 3 MRI.
Timepoint [2] 258335 0
Follow-up of patients will be performed for at least 6 months after study entry to determine outcome. Follow-up will be until the censorship date (when all patients have been followed for at least 6 months) or until deceased.
Primary outcome [3] 258336 0
Progression-free survival. Patients will be followed clinically to determine outcome. Progression will be determined by MRI scans, performed 3 monthly or more frequently if required. Radiological progression will be defined as per the Macdonald criteria (MacDonald DR, Cascino TL, Schold SC, Cairncross JG. 1990. Response Criteria for Phase II studies of Supratentorial Malignant Glioma. J Clin Oncol;8(7):1277-1280), with 25% or more increase in the size of the product of the cross-sectional diameters of the enhancing tumour, or unequivocal presence of new lesions
Timepoint [3] 258336 0
6 months. Progression free survival will be measured both from date of diagnosis (ie: date of original pathological diagnosis) and from date of post cycle 2 or 3 MRI. Follow-up will be until the censorship date (when all patients have been followed for at least 6 months ) or until progression has been confirmed.
Secondary outcome [1] 264054 0
Nil
Timepoint [1] 264054 0
Nil

Eligibility
Key inclusion criteria
Histologically confirmed malignant glioma (grades III-IV), Received surgical biopsy or debulking, radiotherapy, and commenced adjuvant chemotherapy with a temozolomide-containing chemotherapy regimen, Planned for routine MRI following 2 or 3 cycles of adjuvant chemotherapy, Eastern Cooperative Oncology Group (ECOG) performance status 0-2, able to undertake MRI and PET-CT imaging, written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy, age less than 18 years, Medical contraindication to MRI or PET-CT imaging, Cognitive impairment considered to impair the ability to give written informed consent in the opinion of the treating clinician

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2010
Actual
21/10/2010
Date of last participant enrolment
Anticipated
Actual
28/11/2012
Date of last data collection
Anticipated
Actual
1/11/2014
Sample size
Target
30
Accrual to date
Final
28
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 256893 0
Commercial sector/Industry
Name [1] 256893 0
Pfizer Australia Pty Ltd
Country [1] 256893 0
Australia
Funding source category [2] 256894 0
Charities/Societies/Foundations
Name [2] 256894 0
Australian and New Zea;and Society of Nuclear Medicine
Country [2] 256894 0
Australia
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital
Address
Hospital Avenue, NEDLANDS, WA, 6009
Country
Australia
Secondary sponsor category [1] 256165 0
None
Name [1] 256165 0
Address [1] 256165 0
Country [1] 256165 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258904 0
Sir Charles Gairdner Group Human Research Ethics Committee
Ethics committee address [1] 258904 0
Hospital Avenue, NEDLANDS, WA, 6009
Ethics committee country [1] 258904 0
Australia
Date submitted for ethics approval [1] 258904 0
Approval date [1] 258904 0
19/11/2009
Ethics approval number [1] 258904 0
2009-127

Summary
Brief summary
This pilot study aims to gain preliminary information on the utility of C-MET and FLT PET-CT imaging for distinguishing ‘pseudoprogression’ from ‘true’ progression in patients receiving chemoradiotherapy for high grade glioma. C-MET and FLT PET-CT scans will be performed at the same time as their routine mid-treatment MRI (after 2-3 cycles of chemotherapy. Patients will be followed to record radiological and clinical responses to chemotherapy. Patients will also be followed up for survival. This data will be used to obtain preliminary information of the prognostic significance of C-MET and FLT PET-CT imaging in glioma
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31111 0
Prof Anna Nowak
Address 31111 0
Medical Oncology Department
B Block
Sir Charles Gairdner Hospital
Hospital Ave
Nedlands, WA, 6009
Country 31111 0
Australia
Phone 31111 0
+61893463841
Fax 31111 0
Email 31111 0
[email protected]
Contact person for public queries
Name 14358 0
Ms Elaine Campbell
Address 14358 0
The Western Australian Positron Emission Tomography (PET) Service
Nuclear Medicine Department
Sir Charles Gairdner Hospital
Hospital Avenue
NEDLANDS, WA 6009
Country 14358 0
Australia
Phone 14358 0
+61 8 9346 2322
Fax 14358 0
+61 8 9346 3610
Email 14358 0
[email protected]
Contact person for scientific queries
Name 5286 0
A/Prof Roslyn Francis
Address 5286 0
The Western Australian Positron Emission Tomography (PET) Service
Nuclear Medicine Department
Sir Charles Gairdner Hospital
Hospital Avenue
NEDLANDS, WA 6009
Country 5286 0
Australia
Phone 5286 0
+61 8 9346 2322
Fax 5286 0
+61 8 9346 3610
Email 5286 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.