COVID-19 studies are our top priority.

For new and updated trial submissions, we are processing trials as quickly as possible and appreciate your patience. We recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
Date results information initially provided
Type of registration
Retrospectively registered

Titles & IDs
Public title
Quantifying the Clinical Benefit of Magnetic Resonance Imaging (MRI) in Lung Cancer Radiotherapy
Scientific title
Quantifying the Clinical Benefit of MRI in Lung Cancer Radiotherapy
Secondary ID [1] 288190 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Cancer 297095 0
Condition category
Condition code
Cancer 297333 297333 0 0
Lung - Non small cell

Study type
Description of intervention(s) / exposure
There is no direct intervention to patients standard treatment.
During the course radiotherapy, participants will receive MRI scans at specified time points to identify changes during the course of treatment,
A total of 6 MRI scans to be performed.
Scan 1 is performed at least 1 week prior to the start of treatment.
Scan 2 is performed on Day 1 of treatment.
Subsequent scans are performed on day 11 and 21 during treatment.
Follow up MRI scans at 3months and 6 months post treatment.
Participants PET and CT scans acquired as part standard radiotherapy planning will be utilised as well.
MRI images acquired for this study will not impact of change treatment intent for participants. All images will be utilised retrospectively.
Intervention code [1] 293492 0
Other interventions
Comparator / control treatment
No control group
Control group

Primary outcome [1] 297011 0
Composite primary outcome of variation in lung tumour delineation and tumour motion between 4DCT plus PET and MRI scans.
Timepoint [1] 297011 0
After baseline MRI scan
Primary outcome [2] 297013 0
Changes in lung tumor volume over the course of treatment
Timepoint [2] 297013 0
After MRI scans on treatment Day 1, 11 and 21
Primary outcome [3] 297014 0
Composite Primary outcome to correlate functional changes seen on diffusion weighted MRI ( change in tumour diffusion) and dynamic contrast enhanced MRI ( change in tumour perfusion) during course of treatment to clinical data collected as part of standard clinical follow-up. e.g. toxicity as per CTCAE v4, ECOG status
Timepoint [3] 297014 0
Asses functional changes during treatment at Day 1, 11 and 21 correlate to treatment outcome 1 year post treatment
Secondary outcome [1] 319847 0
A composite secondary outcome to evaluate the changes seen in normal lung tissue on CT and MRI scans taken during radiotherapy treatment and correlate this with clinical toxicity outcomes based on common terminology criteria (CTCAE) V4 .
Timepoint [1] 319847 0
3 and 6 months after treatment completion

Key inclusion criteria
1) Histological or cytological confirmed lung cancer
3) Patient has good renal function ( GFR < 53ml/min)
4) Patient is receiving 12 or more fractions of treatment
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Contraindication to MRI
Prior surgery to area of treatment

Study design
Purpose of the study
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 0
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 5024 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 5025 0
Campbelltown Hospital - Campbelltown

Funding & Sponsors
Funding source category [1] 292666 0
Name [1] 292666 0
Radiation Oncology - Liverpool Cancer Therapy Centre
Address [1] 292666 0
Liverpool Cancer Therapy
Radiation Oncology
Locked Bag 7103
Liverpool BC, NSW, 1871 Australia
Country [1] 292666 0
Primary sponsor type
Liverpool Cancer Therapy Centre
Liverpool Cancer Therapy
Radiation Oncology
Locked Bag 7103
Liverpool BC, NSW, 1871 Australia
Secondary sponsor category [1] 291387 0
Name [1] 291387 0
Address [1] 291387 0
Country [1] 291387 0

Ethics approval
Ethics application status
Ethics committee name [1] 294138 0
Research and Ethics Office, South Western Sydney Local Health District
Ethics committee address [1] 294138 0
Locked Bag 7103,
Liverpool BC,
NSW 1871
Ethics committee country [1] 294138 0
Date submitted for ethics approval [1] 294138 0
Approval date [1] 294138 0
Ethics approval number [1] 294138 0

Brief summary
This study aims to quantify clinical benefit of Magnetic resonance imaging (MRI) during lung cancer radiotherapy.
Who is it for? Participants aged 18 years or over and have histological or cytological confirmed lung cancer scheduled to be treated with 12 or more fractions of treatment.
Study details: All participants in this study will undergo MRI scans in addition to standard scans used during radiotherapy treatment (CT and PET). Participant of this trial will undergo a total of six MRI scans which will be performed before radiotherapy treatment starts, and at treatment day 1, day 11 and day 21 (where applicable), and three and six months post treatment completion. MRI scans acquired will not alter or impact participant’s treatment intent.This study will not impact on the participants standard treatment.

Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 62302 0
Mrs Shivani Kumar
Address 62302 0
Liverpool Cancer Therapy
Radiation Oncology
Locked Bag 7103
Liverpool BC, NSW, 1871
Country 62302 0
Phone 62302 0
+61 2 87389402
Fax 62302 0
Email 62302 0
Contact person for public queries
Name 62303 0
Mrs Shivani Kumar
Address 62303 0
Liverpool Cancer Therapy
Radiation Oncology
Locked Bag 7103
Liverpool BC, NSW, 1871
Country 62303 0
Phone 62303 0
+612 87389402
Fax 62303 0
Email 62303 0
Contact person for scientific queries
Name 62304 0
Mrs Shivani Kumar
Address 62304 0
Liverpool Cancer Therapy
Radiation Oncology
Locked Bag 7103
Liverpool BC, NSW, 1871
Country 62304 0
Phone 62304 0
+612 87389402
Fax 62304 0
Email 62304 0

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary