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Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12611000549921
Ethics application status
Approved
Date submitted
27/05/2011
Date registered
30/05/2011
Date last updated
21/12/2018
Date data sharing statement initially provided
21/12/2018
Date results information initially provided
21/12/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
Comparison of magnetic resonance imaging (MRI) and angio computed tomography ( Angio CT) in the characterization of liver lesions in patients with colorectal cancer and possible liver metastases
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Scientific title
Comparison of magnetic resonance imaging (MRI) and angio computed tomography ( Angio CT) in the characterization of liver lesions in patients with colorectal cancer and possible liver metastases
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Secondary ID [1]
262268
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nil
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Universal Trial Number (UTN)
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Trial acronym
nil
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
colorectal cancer liver metastases
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Condition category
Condition code
Cancer
268102
268102
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0
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Liver
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Cancer
268111
268111
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0
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Bowel - Back passage (rectum) or large bowel (colon)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
patients will undergo primovist MRI as part of their work up for presentation with colorectal cancer liver metastases (CRCLM)
most patietns will undergo one MRI but may have a second if they need neoadjuvant chemotherapy and then restaging for possible surgery.
MRI usually takes about 30 minutes.
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Intervention code [1]
266659
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Diagnosis / Prognosis
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Intervention code [2]
266668
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Treatment: Drugs
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Comparator / control treatment
patients will undergo Angio CT which is usual practice in the work up for CRCLM
as with MRI patients will undergo angio CT on more than one occassion if tehy need restaging after chemotherapy. this is our standard practice and not done differently in this study.
the angio CT takes about 4 hours. 15 minutes for catherter placement, 15 minutes for scanning, and 4 hours llying flat after catheter is removed from groin.
it is hoped angio CT and MRI will be done on the same day or within one day of each other.
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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assessing accuracy of primovist MRI compared to angio CT.
both tests will be reported by 2 radiologists blinded to results of the other imaging modality.
tis will allow assessment of interobserver variability as well as accuracy of test. all 4 reports will be correlated with histopathology from surgery to assess accuracy of the tests.
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Assessment method [1]
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Timepoint [1]
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measured postoperatively when histopathology available
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Secondary outcome [1]
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identification of false positves in either angioCT or primovist MRI
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Assessment method [1]
276495
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Timepoint [1]
276495
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when histopathology available
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Eligibility
Key inclusion criteria
all patients with CRCLM presenting for consideration for resection
speak english
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Minimum age
18
Years
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Maximum age
85
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Patients under the age of 18;
Patients over the age of 85;
Poor English and no interpreter present;
Renal imparement as this is a contraindication of both Angio CT and some MR contrasts;
Patients with permanent cardiac pacemakers or implantable devices which make them ineligable for the MR study.
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
all consecutive patients will be offered participation in the study
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
14/06/2011
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Actual
14/06/2011
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Date of last participant enrolment
Anticipated
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Actual
8/05/2013
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Date of last data collection
Anticipated
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Actual
1/04/2014
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Sample size
Target
160
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Accrual to date
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Final
160
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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St George Hopsital
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Address [1]
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gray street
Kogarah
NSW 2217
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Country [1]
267146
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Australia
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Primary sponsor type
Individual
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Name
jai seema bagia
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Address
Illawarra oncology suites
410 crown street
Wollongong 2500
NSW
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Country
Australia
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Secondary sponsor category [1]
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Individual
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Name [1]
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derek glenn
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Address [1]
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Dept radiology
st george hospital
short street
kogarah 2217
nsw
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Country [1]
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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south eastern sydney local health network human research ethics committee southern sector (EC00135) (HREC)
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Ethics committee address [1]
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research Support Office
level 3 James Laws House
St George Hospital
Gray Street, Kogarah NSW 2217
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
269136
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Approval date [1]
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10/05/2011
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Ethics approval number [1]
269136
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HREC/10/STG/124
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Summary
Brief summary
This study aims to compare the accuracy of two different diagnostic tests used to examine liver lesions in patients with colorectal cancer.
Who is it for?
You can join this study if you are aged 18 to 85 years and have colorectal cancer liver metastases for which you are considering surgery.
Trial details
Participants in this trial will undergo an Angio CT scan and an MRI with Primovist scan. The Angio CT is a very useful standard test which is used to detect lesions within the liver. The test is also very good at showing the relationship of the lesions to the important blood vessels within the liver. However, sometimes this CT picks up lesions which might not be colorectal cancer metastases (a deposit of colorectal cancer within the liver). It is important to know this so that patients are not excluded from surgery because they have too much disease. It is thought that MRI with Primovist may be better at characterising the liver lesions, i.e. MRI with Primovist is better at deciding whether a lesion seen is a colorectal metastases or not. There has never been a study that directly compares Angio CT with MRI with Primovist. This study would aim to make this comparison. It would help us decide which is the better test in different circumstances to assess the liver disease in a patient with colorectal cancer.
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Trial website
nil
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Trial related presentations / publications
nil
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Public notes
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Contacts
Principal investigator
Name
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Dr JAI Seema Bagia
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Address
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Illawarra Oncology Suites
410 Crown Street
Wollongong 2500
NSW
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Country
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Australia
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Phone
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+61 2 42 273733
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Dr Jai Seema Bagia
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Address
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Illawarra oncology suites
410 Crown Street
Wollongong 2500
NSW
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Country
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Australia
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Phone
15915
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+61 2 42273733
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Fax
15915
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no fax
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Email
15915
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[email protected]
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Contact person for scientific queries
Name
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Dr Dr Jai Seema Bagia
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Address
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Illawarra Oncology suites
410 Crown Street
Wollongong 2500
NSW
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Country
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Australia
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Phone
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+ 61 2 42273733
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
confidentiality
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
885
Diagnostic test accuracy comparison of CT during a...
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Results publications and other study-related documents
Documents added manually
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Study results article
Yes
JS Bagia Alan Chai, Roger Chou, Chris Chu, John Ro...
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Other files
No
presented at international meetings Diagn...
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Documents added automatically
No additional documents have been identified.
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