Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000815369p
Ethics application status
Submitted, not yet approved
Date submitted
1/06/2017
Date registered
5/06/2017
Date last updated
5/06/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Molecular-guided PET/MRI (Positron Emission Tomography/Magnetic Resonance Imaging) to target hypoxia in Glioblastoma (GBM): A Pilot Study.
Scientific title
Using molecular-guided PET/MRI (Positron Emission Tomography/Magnetic Resonance Imaging) to target hypoxia in glioblastoma (GBM): A pilot study to identify novel pathways and define molecular signatures associated with hypoxia and poor patient outcome
Secondary ID [1] 292103 0
Ni Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glioblastoma 303522 0
Condition category
Condition code
Cancer 302933 302933 0 0
Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
F-DOPA and F-MISO PET/MRI (Positron Emission Tomography/Magnetic Resonance Imaging) scan will be performed at Herston Imaging Research Facility (HIRF) by a qualified Nuclear Medicine Technologist and Radiographer.
F-MISO 370MBq will be injected into the patient, two hours prior to the scan being performed in order for uptake to occur. 15 minutes after starting image acquisition, FDOPA 150MBq will be injected with the patient in the scanner and scanning will continue for another 75 minutes. The total scan time will be 90 minutes and the total time participants will be required at HIRF will be 3.5 Hours. The imaging session will be performed within five days prior to the planned Neurosurgery.
The images obtained will be exported to neuronavigation software for use in theatre to allow for biopsy to be performed on targeted areas.

Participants will be separately consented for maximal safe resection by their nominated Neurosurgeon for their suspected high grade glioma (glioblastoma) with tissue biobanking. This is part of the current standard consent process and will be performed by the surgical team not the investigator consenting the patient to the current study.
During the surgical resection tissue will be collected by trained and approved QIMR Berghofer laboratory personnel. The de-identified samples will be clearly labeled as research material and transported in a double-container as per safety regulations on ice to the laboratory.
Intervention code [1] 298245 0
Diagnosis / Prognosis
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302330 0
Successful conduct of F-DOPA, F-MISO PET concurrently with MRI prior to surgery in patients with suspected high-grade glioma.

This will be assessed by the ability for the images obtained to be used in the operating theatre in order to guide targeted bio-banking.
Timepoint [1] 302330 0
Diagnosis
Primary outcome [2] 302331 0
Successful use of F-DOPA and F-MISO MRI images to identify subvolumes of interest within suspected high-grade glioma, and direct intra-operative biopsies.

This will be assessed by the ability to obtain samples from targeted areas identified from the imaging.
Timepoint [2] 302331 0
Time of surgical resection
Secondary outcome [1] 335508 0
Studying agreement of advanced MRI sequences (BOLD, DCE, DWI) with F-DOPA and F-MISO uptake on PET
Timepoint [1] 335508 0
Diagnosis
Secondary outcome [2] 335509 0
Exploratory Laboratory studies – using NanoString technology to understand the transcriptional expression of hypoxic proliferating areas vs non-hypoxic proliferating areas. Exploratory Laboratory tests will be performed on biopsy material obtained during surgery.
Timepoint [2] 335509 0
Post surgical resection

Eligibility
Key inclusion criteria
Aged 18 years or older
Has provided written, informed consent for participation in this trial
History, clinical findings and imaging including MRI considered highly suspicious for high grade glioma
Planned for debulking surgery by neurosurgery
Willing to consent or already consented to “The expression of developmental genes in tumours and blood disorders” Tissue Banking project.
Considered clinically appropriate to undergo preoperative functional imaging and MRI scans at Herston Imaging Research Facility (HIRF)
ECOG performance status 2 or less
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Only surgical procedure planned is open or needle biopsy (<50% of tumour volume)
Women who are pregnant or lactating
Previous surgery or radiotherapy to brain for any indication
Previous chemotherapy for any indication
Prior diagnosis of cancer (excluding successfully treated basal cell or squamous cell carcinoma of the skin)
Any clinical or radiologic evidence of metastatic malignancy

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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/07/2017
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
5
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 296635 0
Hospital
Name [1] 296635 0
Royal Brisbane and Women's Hospital Herston Imaging Research Facility (HIRF) Seed Funding
Country [1] 296635 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane and Women's Hospital
Address
Royal Brisbane and Women's Hospital
Butterfield Street
Herston Queensland Australia 4029
Country
Australia
Secondary sponsor category [1] 295597 0
None
Name [1] 295597 0
Address [1] 295597 0
Country [1] 295597 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 297866 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 297866 0
Royal Brisbane and Women's Hospital
Level 7 Block 7
Herston Road Herston
Queensland Australia 4029
Ethics committee country [1] 297866 0
Australia
Date submitted for ethics approval [1] 297866 0
24/03/2017
Approval date [1] 297866 0
Ethics approval number [1] 297866 0

Summary
Brief summary
The purpose of this study is to evaluate the feasibility of using a newly available combined PET-MRI platform to identify hypoxic areas in patients with glioblastoma (GBM) to target during surgery.

Who it is for?
You may be eligible to join this study if you are aged 18 years or above and have suspected high grade glioma for which surgery is planned.

Study details
All participants in this study will undergo PET/MRI (Positron Emission Tomography / Magnetic Resonance Imaging) at Herston Imaging Research Facility (HIRF). A qualified Nuclear Medicine Technologist will insert a tube into a vein in your arm and give you an injection of a radioactive substance called F-MISO. You will then be required to wait for 2 hours, called the uptake time, before emptying your bladder and proceeding to have your scan. The scan involves lying flat with knees supported. Fifteen minutes after the start of your scan a qualified Nuclear Medicine Technologist will give you a further injection of a radioactive substance called F-DOPA. The PET camera and MRI will scan your head including your whole brain. The scan time will be approximately 90 minutes and the scan is painless. The experience of the scan itself will be similar to an MRI which you may already have had. Hypoxic areas identified in the PET/MRI will subsequently be targeted during surgery.

Key outcomes include feasibility, and comparison of PET/MRI results to biopsies taken during surgery. Demonstrating feasibility of pre-operative combined PET/MRI for glioma would of itself be useful for patients as it reduces the overall number of scans they have to attend in the limited time between presentation and resection.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75314 0
Dr Benjamin Chua
Address 75314 0
Royal Brisbane and Women's Hospital
Cancer Care Services
Butterfield Street
Herston Queensland Australia 4029
Country 75314 0
Australia
Phone 75314 0
+61 7 3646 8111
Fax 75314 0
Email 75314 0
Benjamin.Chua@health.qld.gov.au
Contact person for public queries
Name 75315 0
Dr Benjamin Chua
Address 75315 0
Royal Brisbane and Women's Hospital
Cancer Care Services
Butterfield Street
Herston Queensland Australia 4029
Country 75315 0
Australia
Phone 75315 0
+61 7 3646 8111
Fax 75315 0
Email 75315 0
Benjamin.Chua@health.qld.gov.au
Contact person for scientific queries
Name 75316 0
Dr Benjamin Chua
Address 75316 0
Royal Brisbane and Women's Hospital
Cancer Care Services
Butterfield Street
Herston Queensland Australia 4029
Country 75316 0
Australia
Phone 75316 0
+61 7 3646 8111
Fax 75316 0
Email 75316 0
Benjamin.Chua@health.qld.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.