Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001075471
Ethics application status
Approved
Date submitted
12/01/2016
Date registered
10/08/2016
Date last updated
10/12/2019
Date data sharing statement initially provided
10/12/2019
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
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
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

Intervention/exposure
Study type
Interventional
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
Uncontrolled

Outcomes
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

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Contraindication to MRI
Prior surgery to area of treatment

Study design
Purpose of the study
Treatment
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
Phase 0
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
29/10/2013
Date of last participant enrolment
Anticipated
29/10/2017
Actual
25/05/2018
Date of last data collection
Anticipated
Actual
8/06/2019
Sample size
Target
36
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 5024 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 5025 0
Campbelltown Hospital - Campbelltown

Funding & Sponsors
Funding source category [1] 292666 0
Hospital
Name [1] 292666 0
Radiation Oncology - Liverpool Cancer Therapy Centre
Country [1] 292666 0
Australia
Primary sponsor type
Hospital
Name
Liverpool Cancer Therapy Centre
Address
Liverpool Cancer Therapy
Radiation Oncology
Locked Bag 7103
Liverpool BC, NSW, 1871 Australia
Country
Australia
Secondary sponsor category [1] 291387 0
None
Name [1] 291387 0
Nil
Address [1] 291387 0
Nil
Country [1] 291387 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294138 0
Research and Ethics Office, South Western Sydney Local Health District
Ethics committee address [1] 294138 0
Ethics committee country [1] 294138 0
Australia
Date submitted for ethics approval [1] 294138 0
16/07/2013
Approval date [1] 294138 0
19/08/2013
Ethics approval number [1] 294138 0
HREC?13/LPOOL/152

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
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
Australia
Phone 62302 0
+61 2 87389402
Fax 62302 0
Email 62302 0
[email protected]
Contact person for public queries
Name 62303 0
Shivani Kumar
Address 62303 0
Liverpool Cancer Therapy
Radiation Oncology
Locked Bag 7103
Liverpool BC, NSW, 1871
Country 62303 0
Australia
Phone 62303 0
+612 87389402
Fax 62303 0
Email 62303 0
[email protected]
Contact person for scientific queries
Name 62304 0
Shivani Kumar
Address 62304 0
Liverpool Cancer Therapy
Radiation Oncology
Locked Bag 7103
Liverpool BC, NSW, 1871
Country 62304 0
Australia
Phone 62304 0
+612 87389402
Fax 62304 0
Email 62304 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


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
SourceTitleYear of PublicationDOI
EmbaseVariability of gross tumour volume delineation: MRI and CT based tumour and lymph node delineation for lung radiotherapy.2022https://dx.doi.org/10.1016/j.radonc.2021.11.036
N.B. These documents automatically identified may not have been verified by the study sponsor.