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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
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
Secondary ID [1] 262268 0
nil
Universal Trial Number (UTN)
Trial acronym
nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
colorectal cancer liver metastases 267972 0
Condition category
Condition code
Cancer 268102 268102 0 0
Liver
Cancer 268111 268111 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 266659 0
Diagnosis / Prognosis
Intervention code [2] 266668 0
Treatment: Drugs
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.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 266847 0
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.
Timepoint [1] 266847 0
measured postoperatively when histopathology available
Secondary outcome [1] 276495 0
identification of false positves in either angioCT or primovist MRI
Timepoint [1] 276495 0
when histopathology available

Eligibility
Key inclusion criteria
all patients with CRCLM presenting for consideration for resection
speak english
Minimum age
18 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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.

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)
all consecutive patients will be offered participation in the study
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
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

Funding & Sponsors
Funding source category [1] 267146 0
Hospital
Name [1] 267146 0
St George Hopsital
Address [1] 267146 0
gray street
Kogarah
NSW 2217
Country [1] 267146 0
Australia
Primary sponsor type
Individual
Name
jai seema bagia
Address
Illawarra oncology suites
410 crown street
Wollongong 2500
NSW
Country
Australia
Secondary sponsor category [1] 266218 0
Individual
Name [1] 266218 0
derek glenn
Address [1] 266218 0
Dept radiology
st george hospital
short street
kogarah 2217
nsw
Country [1] 266218 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269136 0
south eastern sydney local health network human research ethics committee southern sector (EC00135) (HREC)
Ethics committee address [1] 269136 0
research Support Office
level 3 James Laws House
St George Hospital
Gray Street, Kogarah NSW 2217
Ethics committee country [1] 269136 0
Australia
Date submitted for ethics approval [1] 269136 0
Approval date [1] 269136 0
10/05/2011
Ethics approval number [1] 269136 0
HREC/10/STG/124

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.
Trial website
nil
Trial related presentations / publications
nil
Public notes

Contacts
Principal investigator
Name 32668 0
Dr JAI Seema Bagia
Address 32668 0
Illawarra Oncology Suites
410 Crown Street
Wollongong 2500
NSW
Country 32668 0
Australia
Phone 32668 0
+61 2 42 273733
Fax 32668 0
Email 32668 0
jsbagia@hotmail.co.uk
Contact person for public queries
Name 15915 0
Dr Dr Jai Seema Bagia
Address 15915 0
Illawarra oncology suites
410 Crown Street
Wollongong 2500
NSW
Country 15915 0
Australia
Phone 15915 0
+61 2 42273733
Fax 15915 0
no fax
Email 15915 0
jsbagia@hotmail.co.uk
Contact person for scientific queries
Name 6843 0
Dr Dr Jai Seema Bagia
Address 6843 0
Illawarra Oncology suites
410 Crown Street
Wollongong 2500
NSW
Country 6843 0
Australia
Phone 6843 0
+ 61 2 42273733
Fax 6843 0
Email 6843 0
jsbagia@hotmail.co.uk

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
confidentiality
What supporting documents are/will be available?
Study protocol
Clinical study report
Ethical approval
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Journal publication details
Publication date and citation/details [1] 880 0
JS Bagia Alan Chai, Roger Chou, Chris Chu, John Rouse, Elizabeth Sinclair, Leon Vonthethoff, Armando Teixeira-Pinto Diagnostic test accuracy comparison of CT during arterial portography and Primovist MRI in preoperative assessment of colorectal cancer liver metastases. HPB. 2015 17 (10) 927-935.
Attachments [1] 880 0
Other publications
Have study results been made publicly available in another format?
Yes
Other publication details
Citation type [1] 881 0
Presentation
Citation/DOI/link/details [1] 881 0
presented at international meetings
Diagnostic test accuracy comparison of CT during arterial portography and Primovist MRI in preoperative assessment of colorectal cancer liver metastases
JS Bagia, A Texiera Pinto et al
EWALT meeting Milan, Italy January 2015
Attachments [1] 881 0
Citation type [2] 885 0
Citation/DOI/link/details [2] 885 0
Diagnostic test accuracy comparison of CT during arterial portography and Primovist MRI in preoperative assessment of colorectal cancer liver metastases – interim results
JS Bagia, A Texiera Pinto et al
EAHPBA Belgrade June 2013

Attachments [2] 885 0
Results – basic reporting
Results – plain English summary