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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
ACTRN12616000523404
Ethics application status
Approved
Date submitted
19/04/2016
Date registered
22/04/2016
Date last updated
12/05/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study looking at the reproducibility of Magnetic Resonance Imaging (MRI) Simulation Scans for Radiotherapy Planning
Scientific title
Uncertainty in Magnetic Resonance Imaging (MRI) Simulation Scans for Radiotherapy Planning
Secondary ID [1] 289043 0
None
Universal Trial Number (UTN)
U1111-1182-1022
Trial acronym
HOHO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer - prostate 298469 0
Cancer - head and neck 298473 0
Cancer - central nervous system 298474 0
Cancer - rectal 298475 0
Cancer - lung 298476 0
Cancer - cervix. 298477 0
Condition category
Condition code
Cancer 298564 298564 0 0
Other cancer types
Cancer 298568 298568 0 0
Prostate
Cancer 298569 298569 0 0
Cervical (cervix)

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The intervention involves an additional MRI scan for participants that will only be used for the purpose of the study and not for the radiotherapy treatment planning. Participants would otherwise be attending for an MRI scan for the purposes of planning for their radiotherapy treatment (simulation) but the intervention is an additional scan. The scan will be performed by a suitably qualified allied health professional. The scan will be performed at only one time point and on the same day as their radiotherapy planning MRI or clinical research MRI and the additional scan will take approximately 15 minutes.
The additional MRI scan will be completed with fewer sequences than the first scan. The sequences used will be one anatomical and one functional imaging sequence (DWI).
Intervention code [1] 294535 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298052 0
To assess the reproducibility of Magnetic resonance Imaging (MRI) setup in the radiotherapy position. This will be assessed through the acquisition of 2 MRI sets of scans which will be fused and compared to determine the consistency of imaging and impact of MRI distortion, landmark positions and contours.
Timepoint [1] 298052 0
At time of MRI scan
Primary outcome [2] 298061 0
To assess the consistency of imaging information considering the magnitude and consistency of anatomical and Diffusion Weighted Imaging (DWI) distortion. This will be assessed through the acquisition of 2 MRI sets of scans which will be fused and compared to determine the consistency of imaging and impact of MRI distortion, landmark positions and contours.
Timepoint [2] 298061 0
At time of MRI scan
Secondary outcome [1] 323103 0
None
Timepoint [1] 323103 0
None

Eligibility
Key inclusion criteria
- Aged 18 years or older
- Patients undergoing a planning MRI for their radiotherapy treatment or research purposes for prostate, head and neck, central nervous system, rectal, lung or cervix cancer
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patient refusal
- Contraindication to MRI, such as pacemakers and embodied metal objects, as assessed with the MRI Safety Questionnaire
- Patients with severe claustrophobia or who are unable to lie still
- Inability to give informed consent

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 5640 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 13098 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 293418 0
Hospital
Name [1] 293418 0
Liverpool Cancer Services Trust Fund
Address [1] 293418 0
1 Elizabeth St, Liverpool NSW 2170
Country [1] 293418 0
Australia
Primary sponsor type
Individual
Name
Liverpool Hospital
Address
1 Elizabeth St, Liverpool NSW 2170
Country
Australia
Secondary sponsor category [1] 292243 0
Individual
Name [1] 292243 0
A/Prof Shalini Vinod
Address [1] 292243 0
Liverpool Cancer Therapy
Liverpool Hospital
1 Campbell St Liverpool
NSW 2170
Country [1] 292243 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294865 0
South Western Sydney Local Health District
Ethics committee address [1] 294865 0
Research and Ethics Office
Locked Bag 7103
Liverpool BC
NSW 1871
Ethics committee country [1] 294865 0
Australia
Date submitted for ethics approval [1] 294865 0
23/11/2015
Approval date [1] 294865 0
14/12/2015
Ethics approval number [1] 294865 0
HREC/15/LPOOL/555

Summary
Brief summary
This study will evaluate the reproducibility of magnetic resonance imaging (MRI) setup of patients in the radiotherapy treatment position and assess how this impacts the image quality for radiotherapy planning and treatment delivery.
Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with prostate, head and neck, central nervous system, rectal, cervix or lung cancer.
Study details: Patients would otherwise be undergoing an MRI scan in the radiotherapy department for their cancer treatment or other research purposes. Patients will undergo a planning MRI scan in the treatment position then the patient would then get off the MRI couch and be set-up for a second MRI scan with limited MRI sequences.
The main purpose of this study is to determine the consistency of positioning and the impact of MRI distortion, landmark positions and contours between scans.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65278 0
A/Prof Shalini Vinod
Address 65278 0
Liverpool Cancer Therapy Centre,
Locked Bag 7103
Liverpool BC
1871 NSW
Country 65278 0
Australia
Phone 65278 0
+61 (0)2 8738 9806
Fax 65278 0
+61 (0)2 8738 9819
Email 65278 0
shalini.vinod@sswahs.nsw.gov.au
Contact person for public queries
Name 65279 0
A/Prof Shalini Vinod
Address 65279 0
Liverpool Cancer Therapy Centre,
Locked Bag 7103
Liverpool BC
1871 NSW
Country 65279 0
Australia
Phone 65279 0
+61 (0)2 8738 9806
Fax 65279 0
+61 (0)2 8738 9819
Email 65279 0
shalini.vinod@sswahs.nsw.gov.au
Contact person for scientific queries
Name 65280 0
A/Prof Shalini Vinod
Address 65280 0
Liverpool Cancer Therapy Centre,
Locked Bag 7103
Liverpool BC
1871 NSW
Country 65280 0
Australia
Phone 65280 0
+61 (0)2 8738 9806
Fax 65280 0
+61 (0)2 8738 9819
Email 65280 0
shalini.vinod@sswahs.nsw.gov.au

No information has been provided regarding IPD availability
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