ANZCTR - Registration

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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 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]

Nil

Universal Trial Number (UTN)

U1111-1184-7776

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Glioblastoma

Condition category

Condition code

Cancer

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]

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]

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]

MR images will obtained 18, 24 and 30 hours post ferumoxytol administration, and all images will be read within 7 days.

Primary outcome [2]

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]

Within six months following the final MRI scan.

Secondary outcome [1]

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]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Otago

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Otago

Address [1]

PO Box 56
Dunedin 9054

Country [1]

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]

Individual

Name [1]

Ahmad Taha

Address [1]

Department of Neurosurgery
Dunedin Hospital, Southern District Health Board
201 Great King Street, Dunedin Central, Dunedin 9016

Country [1]

New Zealand

Secondary sponsor category [2]

Individual

Name [2]

Noelyn Hung

Address [2]

Department of Pathology, Dunedin School of Medicine, University of Otago, PO Box 56.
Dunedin 9054

Country [2]

New Zealand

Other collaborator category [1]

Individual

Name [1]

Jean Zhou

Address [1]

Department of Radiology,
Dunedin Hospital, Southern District Health Board
201 Great King Street, Dunedin Central, Dunedin 9016

Country [1]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Central Health and Disability Ethics Committee

Ethics committee address [1]

Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

01/11/2017

Approval date [1]

21/12/2017

Ethics approval number [1]

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

Dr Ahmad Taha

Address

Department of Neurosurgery
Dunedin Hospital, Southern District Heath Board.
201 Great King Street, Dunedin Central, Dunedin 9016

Country

New Zealand

Phone

+64 27254 1243

Fax

ahmad.taha@southerndhb.govt.nz

Contact person for public queries

Name

Tania Slatter

Address

Department of Pathology
Dunedin School of Medicine
University of Otago
PO Box 56
Dunedin 9054

Country

New Zealand

Phone

+64 211104733

Fax

tania.slatter@otago.ac.nz

Contact person for scientific queries

Name

Tania Slatter

Address

Department of Pathology
Dunedin School of Medicine
University of Otago
PO Box 56
Dunedin 9054

Country

New Zealand

Phone

+64 211104733

Fax

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.	Type	Email
14631	Ethical approval	tania.slatter@otago.ac.nz
14843	Informed consent form	tania.slatter@otago.ac.nz
14844	Study protocol	tania.slatter@otago.ac.nz

Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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