Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001287628
Ethics application status
Approved
Date submitted
23/11/2014
Date registered
10/12/2014
Date last updated
21/12/2018
Date data sharing statement initially provided
21/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving preoperative staging in patients with locally resectable pancreatic cancer – a randomised controlled trial comparing 12 month recurrence rate of patients managed with standard preoperative assessment of liver metastases, contrast enhanced CT( computed tomography) to preoperative assessment of liver metastases with Primovist (liver specific contrast) MRI ( magnetic resonance imaging )
Scientific title
patients with locally resectable pancreatic cancer
randomized to standard preoperative assessment or additional primovist MRI to further evaluate for liver metastases
comparing 12 month recurrence rate between the 2 groups
Secondary ID [1] 285721 0
none
Universal Trial Number (UTN)
Trial acronym
PCLM study
pancreas cancer liver metastases study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pancreas adenocarcinoma 293605 0
Condition category
Condition code
Cancer 293892 293892 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
primovist MRI
patients will undergo primovist MRI as part of their work up for presentation with locally resectable pancreatic cancer

An MRI is a scan, which does not expose the patient to any ionizing radiation. A contrast agent is injected through a cannula, usually in the arm. Patients are then required to lay flat on their back for the duration of the scan, which is usually about 35 minutes. The contrast injected in this situation would be Primovist.
Primovist is a liver specific contrast, which helps characterize liver lesions in MRI more accurately. It has been available since 2005 and is used with increasing confidence in many liver centres. It is TGA approved but not yet available on Medicare.

the primovist MRI will be in addition to the multiphase CT as this is the usual test to assess the liver but also the pancreas cancer and its relationship to vessels and the chest for disease.
most patients will undergo one MRI but may undergo a second if they are given neoadjuvant chemotherapy as they will then need restaging for possible surgery.
Intervention code [1] 290678 0
Diagnosis / Prognosis
Comparator / control treatment
patients with locally resectable pancreatic cancer will undergo standard preoperative assessment

This is a multiphase CT of abdomen and contrast CT of chest
Control group
Active

Outcomes
Primary outcome [1] 293670 0
recurrence rate

evaluated with multiphase CT chest abdomen and pelvis and tumor marker Ca 19-9 every 3 months ( as is usual followup in this group)
Timepoint [1] 293670 0
12 months
Secondary outcome [1] 311541 0
liver metastases as seen on CT, MRI or PET

however only CT is part of routine followup
if other modalities are used as part of clinical workup to further evaluate a finding the information from this imaging will be noted
Timepoint [1] 311541 0
12 months

Eligibility
Key inclusion criteria
Sex: Male and Females

Age range: 18-85

Disease status: Locally operable pancreatic adenocarcinoma diagnosed by CT +- elevated tumour markers +- cholangiography +- cytology.

No liver metastases on CT staging.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with significant renal impairment, which precludes them having the CT, contrast or Primovist contrast for the MRI would be excluded.

Women lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study.

Patients with a history of renal disease with an EGFR less than 40.

Patients with a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study.

Patients with devices that exclude them from Primovist MRI will be excluded from the study, in particular, patients with pacemakers and/or implantable devices.

Patients unwilling and unable to give written informed consent to participate in the study. Patients unable to understand study information with the help of an interpreter.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The participant will be enrolled into the study after the informed consent process has been completed and the participant has met all the inclusion criteria and none of the exclusion criteria. The patient details will be forwarded to the central office, which will allocate randomisation, record and track the study progress.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Given the nature of the study it will not be possible to blind the patients or the physicians involved the study. We will use blocked randomization to ensure a 2 to 1 randomization. We will use the randomization tool RANDI2, available at http://dschrimpf.github.io/randi3/.

At the beginning of the study we will produce a set of 24 of numbered and sealed envelopes with the sequence of group allocation, according to the randomization. The envelopes will be kept at the project headquarters and for each new patient entering the study an envelope will be opened to define his/hers trial arm.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis


Pilot study of 24 patients to test the planned methods and procedures, including the feasibility of recruiting from this patient group and also to support an application for further funding to extend the study. We aim to establish preliminary estimates of 3 phase CT and Primovist MRI detection rates of liver metastases and 12-month recurrence risk.

The largest number of patients we can expect to recruit in this time, over the listed sites is about 24. It is our intention to complete recruitment to the pilot close to the time we expect to commence the larger study so that we do not lose the familiarity and momentum developed amongst the local clinicians before we start recruitment to the larger study.

Also it may give us some realistic appreciation of the differences between 3 phase CT and Primovist MRI detection rates, which would complement our existing information and assumptions for the sample size calculations for the larger study.



The sample is underpowered to test differences between the two groups. However, this is a pilot study. Twenty-four patients provide 60% power to detect a reduction from 70% to 25%, for a significance level of 0.05.



Patient’s characteristics will be summarised by study arm to assess the comparability of the groups. The main analysis will be the estimation of the risk of recurrence at 12 months in the two arms. Exact 95% confidence intervals will be provided for the risk estimates. Additionally, we will use Fisher’s exact test to compare the two risks.



Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2022
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 290298 0
Self funded/Unfunded
Name [1] 290298 0
Country [1] 290298 0
Primary sponsor type
Individual
Name
jai seema bagia
Address
jai seema bagia
Illawarra oncology suites
410 crown street
Wollongong 2500
NSW
Country
Australia
Secondary sponsor category [1] 289008 0
None
Name [1] 289008 0
Address [1] 289008 0
Country [1] 289008 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302248 0
HREC South eastern sydney local health district
Ethics committee address [1] 302248 0
Ethics committee country [1] 302248 0
Australia
Date submitted for ethics approval [1] 302248 0
Approval date [1] 302248 0
21/11/2013
Ethics approval number [1] 302248 0

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

Contacts
Principal investigator
Name 52966 0
Dr jai seema bagia
Address 52966 0
Illawarra oncology suites
410 Crown street
Wollongong 2500
NSW
Country 52966 0
Australia
Phone 52966 0
+ 61 2 42 273733
Fax 52966 0
Email 52966 0
jsbagia@hotmail.co.uk
Contact person for public queries
Name 52967 0
jai seema bagia
Address 52967 0
Illawarra oncology suites
410 Crown street
Wollongong 2500
NSW
Country 52967 0
Australia
Phone 52967 0
+ 61 2 42 273733
Fax 52967 0
Email 52967 0
jsbagia@hotmail.co.uk
Contact person for scientific queries
Name 52968 0
jai seema bagia
Address 52968 0
Illawarra oncology suites
410 crown street
Wollongong 2500
nsw
Country 52968 0
Australia
Phone 52968 0
+ 61 2 42 273733
Fax 52968 0
Email 52968 0
jsbagia@hotmail.co.uk

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 Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.