Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000217707
Ethics application status
Approved
Date submitted
11/01/2022
Date registered
7/02/2022
Date last updated
7/02/2022
Date data sharing statement initially provided
7/02/2022
Date results information initially provided
7/02/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Pilot Interventional Study to Investigate using Ferumoxytol as an MRI Contrast Agent for Imaging Brain Tumours.
Scientific title
A Pilot Interventional Study to Determine the Diagnostic Utility of the Ferumoxytol MRI Tracking Scan in Patients with Glioblastoma Undergoing Oncology Treatment
Secondary ID [1] 306161 0
Nil
Universal Trial Number (UTN)
U1111-1184-7776
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glioblastoma 324872 0
Condition category
Condition code
Cancer 322307 322307 0 0
Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The participants will receive an one-off intravenous iron infusion (the iron oxide compound ferumoxytol, 2.6mg/kg of Feraheme™ diluted in 100 ml of normal saline by a radiologist, radiology registrar or surgical registrar, and administered over 30 minutes. At 18, 24, and 30 hours post ferumoxytol infusion participants will receive an MRI to determine the optimal timing to detect the best brain tumour images. Each MRI scan is approximately 40 minutes. Once the tumour is excised it will be checked for iron using special stains for iron.
Intervention code [1] 322571 0
Diagnosis / Prognosis
Comparator / control treatment
Each patient acts as their own control standard: brain tumour images following gadolinium MRI are compared to those following ferumoxytol infusion and MRI. The gadolinium contrast MRI will occur 1-5 days prior to the ferumoxytol-MRI. Gadolinium will be administered by a radiologist or radiology registrar. The gadolinium MRI is approximately 40 minutes. Gadolinium (0.1mmol/kg (standard)-0.2 mmol/kg (maximum)) will be administered by intravenous infusion and the MRI started within 10 minutes after gadolinium administration. The MRI image is examined within 24 hours (T1 weighted) to check that the gadolinium was administered.
Control group
Active

Outcomes
Primary outcome [1] 330071 0
To find the optimal time interval post ferumoxytol to image brain tumours. This will be assessed by viewing the fermoxytol-images (T1, T2, Flair, susceptibility weighted sequence (SWI) and post contrast T1 sequences) by at least two radiologists. Each image will be read in the Public Hospital Patient Archive Communication System (PACS). The time associated with the best contrast image will be selected. The time associated with the best contrast image will be assessed using all images as a composite primary outcome.
Timepoint [1] 330071 0
MR images will obtained 18, 24 and 30 hours post ferumoxytol administration, and all images will be read within 7 days.
Primary outcome [2] 330072 0
Diagnostic accuracy of ferumoxytol contrast MRI assessed by viewing T1, T2, Flair, susceptibility weighted sequence (SWI) and post contrast T1 MRI sequences by at least two radiologists, using gadolinium MRI sequences as the gold standard. Each image will be read in the Public Hospital Patient Archive Communication System (PACS). All images will be compared as a composite primary outcome.
Timepoint [2] 330072 0
Within six months following the final MRI scan.
Secondary outcome [1] 404801 0
To determine the safety and tolerability of ferumoxytol in glioblastoma patients. Adverse events assessed in accordance with the Common Terminology Criteria for Adverse Events (CTCAE5.0) based on participant self-report. Blood pressure, heart rate, and respiratory rate measured using a pulse oximeter, electrocardiograph, and spirometer measured by the radiologist, radiology registrar, or surgical registrar administrating the ferumoxytol.
Timepoint [1] 404801 0
Participant blood pressure, heart rate or respiratory rate measured immediately before the ferumoxtyol infusion, immediately after the infusion, and 30 minutes, 1 hour, 2 hours, 6 hours, 12 hours, 24 hours and then every 24 hours until the ferumoxytol-MRI. Participant self report immediately before the ferumoxtyol infusion, immediately after the infusion, and 30 minutes, 1 hour, 2 hours, 6 hours, 12 hours, 24 hours and then every 24 hours until the ferumoxytol infusion, and 2 months, 4 months, and 6 months following ferumoxytol infusion.

Eligibility
Key inclusion criteria
1. Patients with an imaging diagnosis of primary glioblastoma
2. No chemotherapy or other treatments (such as steroids) have been administered to the patients between the rime of the baseline diagnostic scan and the ferumoxytol infusion.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients who are younger than 18 years old.
2. Patients who are pregnant or breast feeding.
3. Patients who have known allergy to iron preparation or other medication allergy.
4. Patients who have haemochromatosis or known clinically significant liver function abnormality.
5. The initial diagnostic MRI demonstrates intracranial haemorrhage, calcification or other susceptibility blooming artifacts.

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
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
28/09/2018
Date of last participant enrolment
Anticipated
Actual
20/05/2020
Date of last data collection
Anticipated
Actual
7/01/2022
Sample size
Target
12
Accrual to date
Final
12
Recruitment outside Australia
Country [1] 24486 0
New Zealand
State/province [1] 24486 0
Otago

Funding & Sponsors
Funding source category [1] 310507 0
University
Name [1] 310507 0
University of Otago
Country [1] 310507 0
New Zealand
Primary sponsor type
Individual
Name
Tania Slatter
Address
Department of Pathology
Dunedin School of Medicine
University of Otago
PO Box 56
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 311672 0
Individual
Name [1] 311672 0
Ahmad Taha
Address [1] 311672 0
Department of Neurosurgery
Dunedin Hospital, Southern District Health Board
201 Great King Street, Dunedin Central, Dunedin 9016
Country [1] 311672 0
New Zealand
Secondary sponsor category [2] 311673 0
Individual
Name [2] 311673 0
Noelyn Hung
Address [2] 311673 0
Department of Pathology, Dunedin School of Medicine, University of Otago, PO Box 56.
Dunedin 9054
Country [2] 311673 0
New Zealand
Other collaborator category [1] 282120 0
Individual
Name [1] 282120 0
Jean Zhou
Address [1] 282120 0
Department of Radiology,
Dunedin Hospital, Southern District Health Board
201 Great King Street, Dunedin Central, Dunedin 9016
Country [1] 282120 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310132 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 310132 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 310132 0
New Zealand
Date submitted for ethics approval [1] 310132 0
01/11/2017
Approval date [1] 310132 0
21/12/2017
Ethics approval number [1] 310132 0
17/CEN/176

Summary
Brief summary
This is a pilot interventional study to investigate using ferumoxytol as a contrast agent for imaging the aggressive primary brain tumour (glioblastoma). The study is testing using a new type of brain scan that uses extremely small iron particles (ferumoxytol) that then become visible in the brain when imaged using MRI. This study will determine if ferumoxytol is safe to use in glioblastoma patients, identify the best time to image brain tumours once ferumoxytol is administered, and if ferumoxytol does provide suitable brain tumour imaging by comparing the imaging to that obtained using standard imaging (with gadolinium as the contrast agent). Participants will receive a 2.6mg/kg total dose of ferumoxytol diluted in 100ml of normal and infused intravenously for 30minutes. Patients receive the infusion as an inpatient in the neurosurgical ward. At different time points following ferumoxytol infusion patients receive a MRI scan. We hypothesise that ferumoxtyol MRI will be safe, well tolerated, and adequate for imaging glioblastomas when compared with gadolinium MRI.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116586 0
Dr Ahmad Taha
Address 116586 0
Department of Neurosurgery
Dunedin Hospital, Southern District Heath Board.
201 Great King Street, Dunedin Central, Dunedin 9016
Country 116586 0
New Zealand
Phone 116586 0
+64 27254 1243
Fax 116586 0
Email 116586 0
ahmad.taha@southerndhb.govt.nz
Contact person for public queries
Name 116587 0
Dr Tania Slatter
Address 116587 0
Department of Pathology
Dunedin School of Medicine
University of Otago
PO Box 56
Dunedin 9054
Country 116587 0
New Zealand
Phone 116587 0
+64 211104733
Fax 116587 0
Email 116587 0
tania.slatter@otago.ac.nz
Contact person for scientific queries
Name 116588 0
Dr Tania Slatter
Address 116588 0
Department of Pathology
Dunedin School of Medicine
University of Otago
PO Box 56
Dunedin 9054
Country 116588 0
New Zealand
Phone 116588 0
+64 211104733
Fax 116588 0
Email 116588 0
tania.slatter@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All the individual participant data collected during the trial after de identification will be shared once the study has been published.
When will data be available (start and end dates)?
Within 7 days of the study being published online. Available for 5 years after publication.
Available to whom?
The publication will be publicly available and in addition to this case by case basis at the discretion of the Primary Sponsor.
Available for what types of analyses?
Published data can be used in meta-analyses.
How or where can data be obtained?
Once the study has been published the link to the paper or a hard-copy of the paper will be available. For case by case analyses the contact details are Dr Tania Slatter (tania.slatter@otago.ac.nz; Department of Pathology, Dunedin School of Medicine, University of Otago, New Zealand.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14631Ethical approval  tania.slatter@otago.ac.nz
14843Informed consent form  tania.slatter@otago.ac.nz
14844Study protocol  tania.slatter@otago.ac.nz



Results publications and other study-related documents

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

Documents added automatically
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