Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000863437
Ethics application status
Approved
Date submitted
8/06/2016
Date registered
1/07/2016
Date last updated
1/06/2022
Date data sharing statement initially provided
9/07/2019
Date results information initially provided
1/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Functional MRI assessment of primary and secondary brain tumour response to radiation therapy: A pilot study
Scientific title
Functional MRI assessment of primary and secondary brain tumour response to radiation therapy: A pilot study
Secondary ID [1] 289399 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Serial CNS MRI Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Brain Cancer 299065 0
Condition category
Condition code
Cancer 299101 299101 0 0
Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study involves observing radiotherapy treatment response using novel MRI sequences as imaging biomarkers in participants undergoing standard radiotherapy and/or chemotherapy treatment.
Standard Treatment - DW, DCE, SWI and ASL MRI at radiotherapy simulation (Radiotherapy treatment planning to map out treatment delivery) (week 0)
Radiotherapy begins at Week 1
Extra test for pts on study
- DW, DCE, SWI and ASL MRI (weeks 3 and 6)
- at 4 weeks post RT - DW, DCE, SWI and ASL MRI
Abbreviations: DW = diffusion weighted; DCE = dynamic contrast enhanced; SWI = susceptibility weighted imaging; ASL = Arterial spin labelling
These scan are to gain anatomical and physiological information.
The MRI images will require administration of an intravenous contrast agent. The MRI scan will take approximately 30-45 minutes and a contrast agent will be administered through a cannula during this examination. The MRIs will be undertaken by clinical MRI and radiotherapy staff with expertise required for clinical use of this imaging modality
Intervention code [1] 294984 0
Diagnosis / Prognosis
Comparator / control treatment
MRI are compared from Week 0 to
- DW, DCE, SWI and ASL MRI (weeks 3 and 6)
- at 4 weeks post RT - DW, DCE, SWI and ASL MRI
Control group
Active

Outcomes
Primary outcome [1] 298569 0
To determine early treatment response and/or disease progression post cancer therapy using novel MRI sequences (including DW and DCE-MRI) in CNS cancer patients.
Timepoint [1] 298569 0
Baseline, Week 3, Week 6 and 4 Weeks post Radiotherapy

Baseline - DW, DCE, SWI and ASL MRI at radiotherapy simulation (week 0)
Weeks 3 and 6 - DW, DCE, SWI and ASL MRI
4 Weeks post RT - DW, DCE, SWI and ASL MRI
Abbreviations: DW = diffusion weighted; DCE = dynamic contrast enhanced; SWI = susceptibility weighted imaging; ASL = Arterial spin labelling
Secondary outcome [1] 324607 0
To document serial hippocampal volumetric changes post cancer therapy using novel MRI sequences.
Timepoint [1] 324607 0
Baseline, Week 3, Week 6 and 4 Weeks post Radiotherapy

Baseline - DW, DCE, SWI and ASL MRI at radiotherapy simulation (week 0)
Weeks 3 and 6 - DW, DCE, SWI and ASL MRI
4 Weeks post RT - DW, DCE, SWI and ASL MRI
Abbreviations: DW = diffusion weighted; DCE = dynamic contrast enhanced; SWI = susceptibility weighted imaging; ASL = Arterial spin labelling

Eligibility
Key inclusion criteria
18 years or older
Have the ability to give informed consent
Histologically-proven primary or secondary brain cancer
Plan to have radiotherapy treatment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Contraindication to MRI studies
Significant claustrophobia
Pacemaker/implantable defibrillator
Implanted metals eg. Intraocular clips
Known allergic reaction to Gd-DTPA

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
Completed
Date of first participant enrolment
Anticipated
14/07/2016
Actual
23/08/2016
Date of last participant enrolment
Anticipated
Actual
1/02/2019
Date of last data collection
Anticipated
Actual
28/03/2019
Sample size
Target
30
Accrual to date
Final
39
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 22479 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 37713 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 293775 0
Hospital
Name [1] 293775 0
Liverpool Hospital
Country [1] 293775 0
Australia
Primary sponsor type
Individual
Name
Dr Eng-Siew Koh
Address
Liverpool Hospital
Elizabeth St & Goulburn St, Liverpool NSW 2170
Country
Australia
Secondary sponsor category [1] 292603 0
None
Name [1] 292603 0
Address [1] 292603 0
Country [1] 292603 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295212 0
South Western Sydney Local Health District
Ethics committee address [1] 295212 0
Elizabeth St & Goulburn St, Liverpool NSW 2170
Ethics committee country [1] 295212 0
Australia
Date submitted for ethics approval [1] 295212 0
27/05/2016
Approval date [1] 295212 0
13/06/2016
Ethics approval number [1] 295212 0

Summary
Brief summary
This pilot study will determine the relationship between of pre-, during treatment and post-radiotherapy (+/- chemotherapy) MRI sequences (including DW and DCE-MRI) with respect to CNS tumour response and local intra-cranial control, post radiotherapy.
and also determine the utility of MRI for assessing changes to the hippocampal region from CNS radiation therapy

Who is it for?
You may be eligible to join this study if you are aged 18 years or above, have been newly diagnosed with primary or secondary brain cancer.

Study details
Participants will undergo normal MRI testing at baseline with an addition of 3 more times.
During RT (Week 3 and 6) and then again 4 weeks post RT
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66534 0
Dr Eng-Siew Koh
Address 66534 0
Liverpool Hospital
Locked Bag 7103, Liverpool BC, NSW 1871
Country 66534 0
Australia
Phone 66534 0
+61 2 8738 9806
Fax 66534 0
+61 2 8738 9819
Email 66534 0
[email protected]
Contact person for public queries
Name 66535 0
Mrs Tess Afinidad
Address 66535 0
Liverpool Hospital
Locked Bag 7103, Liverpool BC, NSW 1871
Country 66535 0
Australia
Phone 66535 0
+61 2 8738 9146
Fax 66535 0
+61 2 8738 9205
Email 66535 0
[email protected]
Contact person for scientific queries
Name 66536 0
Dr Michael Jameson
Address 66536 0
1 Campbell St, Liverpool NSW 2170
Country 66536 0
Australia
Phone 66536 0
+61 2 8738 9219
Fax 66536 0
Email 66536 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will be analysed to show trends within the cohort


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.