Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001114639
Ethics application status
Approved
Date submitted
18/08/2014
Date registered
21/10/2014
Date last updated
9/12/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Determining prognosis and treatment response: novel imaging modalities for Glioblastoma
Scientific title
Clinical utility of F18-ethyl-L-thyrosine (F18-FET) Positron Emission Tomography (PET) imaging, pre and post-radiotherapy, to assess prognosis and treatment response in high-grade glioma.
Secondary ID [1] 285185 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glioblastoma 292786 0
Condition category
Condition code
Cancer 293085 293085 0 0
Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
O-(2-[18F]-fluoroethyl)-L-tyrosine Positron Emission Tomography (FET-PET) scans will be performed on all study participants pre and post radiotherapy. Patients will be instructed to fast for a minimum of 4 hours prior to administration of 200 MBq of F18-FET through an iv cannula. Pre-treatment scans are within 4 weeks of start of radiotherapy and post-treatment scans are 7-14 days after completion of radiotherapy. The first 20 participants (Group A) will undergo an additional pre-treatment PET scan 7-10 days after the first pre-treatment PET scan (a total of 3 PET scans). The remainder of participants (group B) will complete 1 pre and 1 post treatment PET scan . Each participant will also provide a small blood sample prior to the first PET scan for future analysis (yet to be determined). Duration of the imaging scan is approximately 30 minutes and patients are imaged immediately after tracer injection.
Intervention code [1] 290050 0
Other interventions
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292947 0
Overall survival (OS) measured from study entry date to date of death or study end date, whichever is earliest. Analysis will occur 18 months after final participant is recruited
Timepoint [1] 292947 0
Follow-up will be from study entry until the censorship date (when all patients have been followed for at least 18 months) or until deceased.
Secondary outcome [1] 309997 0
Progression-free survival (PFS)
Timepoint [1] 309997 0
Will be measured from study entry date until disease progression, as defined by the MacDonald criteria, or to study end date, whichever is earliest.
Secondary outcome [2] 309998 0
Time to Progression (TTP)
Timepoint [2] 309998 0
Measured from study entry date until disease progression is determined based on the MacDonald criteria
Secondary outcome [3] 310919 0
Diagnosis of pseudoprogression
Timepoint [3] 310919 0
Evidence of pseudoprogression will be assessed retrospectively, and will be based on a combination of radiological evidence on MRI scans, corticosteroid dose and Clinical status from study enrolement date until study end date.

Eligibility
Key inclusion criteria
Patients with newly diagnosed, histologically confirmed glioblastoma grade IV.
Planned to undergo radiotherapy or combined chemoradiotherapy
ECOG performance status 0-2
Able to undertake PET imaging
Able to provide 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 < 18 yrs
Medical contraindication to PET imaging
Cognitive impairment resulting in inability to provide informed consent.

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
Recruiting
Date of first participant enrolment
Anticipated
1/09/2014
Actual
1/10/2014
Date of last participant enrolment
Anticipated
5/02/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 2897 0
Sir Charles Gairdner Hospital - Nedlands

Funding & Sponsors
Funding source category [1] 289799 0
Charities/Societies/Foundations
Name [1] 289799 0
Cancer Council WA
Country [1] 289799 0
Australia
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital
Address
Hospital Avenue
NEDLANDS
WA
6009
Country
Australia
Secondary sponsor category [1] 288489 0
University
Name [1] 288489 0
University of Western Australia
Address [1] 288489 0
School of Medicine and Pharmacology
5th Floor
Harry Perkins Institute of Medical Research QEII Medical Centre
Nedlands, Western Australia, 6009
Country [1] 288489 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291532 0
Sir Charles Gairdner Group (SCGG) Human Research Ethics Committee
Ethics committee address [1] 291532 0
Sir Charles Gairdner Hospital
2nd floor, A Block
Hospital Avenue
QEII Medical site
NEDLANDS
WA 6009
Ethics committee country [1] 291532 0
Australia
Date submitted for ethics approval [1] 291532 0
21/03/2014
Approval date [1] 291532 0
24/06/2014
Ethics approval number [1] 291532 0
2014-004

Summary
Brief summary
This study is investigating the effectiveness of new imaging techniques in determining prognosis and treatment response in patients with glioblastoma. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been newly diagnosed with glioblastoma grade IV, for which your are planned to undergo radiotherapy or combined chemoradiotherapy. Study details All participants in this study will undergo either 2 (group B) or 3 (group A) PET scans, scheduled around their routine radiotherapy, these scans would not normally be part of their routine care. The scans are known as O-(2-[18F]-fluoroethyl)-L-tyrosine Positron Emission Tomography (FET-PET), and involve injection of a radioactive tracer to perform a PET scan. You will need to fast for a minimum of 4 hours before the scan. You will also need to provide a small blood sample when attending for your first PET scan. We will also ask for permission to access tumour tissue samples that were collected during your previous surgery. Participants will be followed up after treatment in order to determine overall survival and disease progression. This information will be used to evaluate the usefulness of the FET-PET scans in predicting prognosis and in identifying treatment-resistant tumours. There are no additional appointments to attend outside your normal treatment visits except for the PET scan visits, which should take approximately one hour. All followup data will be collected from your medical notes when you attend your routine treatment appointments.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50766 0
A/Prof Roslyn Francis
Address 50766 0
Associate Professor of Molecular Imaging
School of Medicine & Pharmacology (M503)
5th Floor, Harry Perkins Institute of Medical Research QEII Medical Centre
Nedlands, Western Australia, 6009
Country 50766 0
Australia
Phone 50766 0
+61 8 6151-0912
Fax 50766 0
+61 8 6151-1027
Email 50766 0
[email protected]
Contact person for public queries
Name 50767 0
Ms Elaine Campbell
Address 50767 0
WA PET Service
Sir Charles Gairdner Hospital
1st floor, G Block
Hospital Avenue
NEDLANDS
WA 6009
Country 50767 0
Australia
Phone 50767 0
+61 8 9346 2322
Fax 50767 0
+61 8 9346 3610
Email 50767 0
[email protected]
Contact person for scientific queries
Name 50768 0
Dr Nelson Loh
Address 50768 0
WA PET Service
Sir Charles Gairdner Hospital
Hospital Avenue
NEDLANDS
WA 6009
Country 50768 0
Australia
Phone 50768 0
+61 8 9346 2322
Fax 50768 0
+61 8 9346 3610
Email 50768 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
SourceTitleYear of PublicationDOI
EmbaseRepeatability of Quantitative 18F-FET PET in Glioblastoma.2021https://dx.doi.org/10.1088/2057-1976/abfae9
N.B. These documents automatically identified may not have been verified by the study sponsor.