None listed
Conditions
Brief summary
This study aims to determine whether the use of Primovist magnetic resonance imaging (MRI) in assessment of pancreatic cancer liver metastases would result in changes in clinical decision-making for these patients and more appropriate treatment decisions. Who is it for? You may be eligible to join this study if you are aged 18 to 85 years old, and have a confirmed diagnosis of locally operable pancreatic adenocarcinoma with no liver metastases on CT staging. Study details Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group undergo primovist MRI in addition to standard multiphase CT of the abdomen and CT of the chest as part of their preoperative assessment for pancreatic resection. This involves an MRI, which 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, and usually takes about 30 minutes. Participants in the other group will undergo standard preoperative assessment which consists of a multiphase CT of abdomen and contrast CT of chest . A CT scan is the current standard scan used to assess pancreas cancer. A cannula for the intravenous contrast is required. There can be discomfort related to its insertion and possible bruising at the site. Although there is exposure to radiation with the CT scan, which is the standard assessment, performed in pancreatic cancer liver assessments there is no additional ionizing radiation from the MRI. All participants will be re-assessed with three monthly CT scans of chest, abdomen and pelvis and tumour markers. Just using CT scans will allow assessment of recurrence, using current standards. The information from follow up scans will allow us to evaluate recurrence rate at 12 months following surgery and the existence of liver metastases. It is hoped that Primovist MRI will be found to be superior to the standard CT tests in the detection of liver metastases in pancreatic cancer, and that this leads to more relevant and appropriate treatment options for patients with pancreatic adenocarcinoma.
Interventions
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,
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.
Sponsors
jai seema bagia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed