An interventional study of Contrast-enhanced Diffusion-weighted MRI in Pancreatic Neoplasms, sponsored by Radboud University Medical Center. Status unknown at 7 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-21.
Sponsored by Radboud University Medical Center · Not applicable, Interventional, and Diagnostic
Given the dismal prognosis of pancreatic cancer, detecting liver metastases early can avoid inappropriate therapy with the associated substantial risks, long-term hospital admissions and high costs, but without survival benefit. The current standard of diagnostic workup with contrast-enhanced CT (CECT) has a poor sensitivity (38-76%) for the detection of liver metastases. As more sophisticated and expensive treatment options emerge, better staging of pancreatic cancer is needed to avoid unnecessary procedures and select the most appropriate treatment strategy. New imaging modalities are available, but their value in staging of pancreatic cancer has not been evaluated yet. Therefore prospective imaging studies are necessary.
The main aim of this study is to determine the diagnostic accuracy of contrast-enhanced diffusion-weighted MRI (CE-DW-MRI) in the detection of liver metastases in patients with pancreatic cancer compared to a reference standard of histopathology and follow up imaging.
The study is an international, multicenter prospective cohort study (inclusion of patients until 138 patients with liver metastases are included, with a total maximum of 465 patients). Patients with pancreatic cancer will undergo additional CE-DW-MRI within two weeks from the CECT. CECT and CE-DW-MRI will be read independently by two radiologists. Suspected liver lesions on CECT and/or CE-DW-MRI will be biopsied to obtain histopathology as reference standard. For liver lesions without histopathologic proof of metastases a paired follow-up CECT and CE-DW-MRI serve as a composite reference standard. Pancreatic resection will be pursued in patients without proven liver or distant metastases. Patients with locally advanced or metastatic disease will be offered palliative treatment. Follow up CECT and CE-DW-MRI will be performed in all patients at 3, 6, and 12 months.
Exclusion Criteria:
Patients with (suspected) pancreatic cancer will undergo additional Contrast-enhanced Diffusion-weighted MRI (CE-DW-MRI) within two weeks from the CECT. Suspected liver lesions on CECT and/or CE-DW-MRI will be biopsied to obtain histopathology as reference standard. For liver lesions without histopathologic proof of metastases a paired follow-up CECT and CE-DW-MRI serve as a composite reference standard. Follow up CECT and CE-DW-MRI will be performed in all patients at 3, 6, and 12 months.
Diagnostic Test: Contrast-enhanced Diffusion-weighted MRI
An MRI scan enhanced with intravenous contrast and with diffusion imaging at several B-values
Diagnostic accuracy of CE-DW-MRI
Sensitivity and Specificity of CE-DW-MRI for the detection of liver metastases in patients with pancreatic cancer compared to CECT.
Time frame: Baseline
Detection of metastasis on CE-DW-MRI in follow-up (3, 6 and 12 months after baseline)
Detection of metastasis with CE-DW-MRI, compared to CECT, in follow-up (3, 6 and 12 months after baseline) of patients with pancreatic cancer, after or during therapy
Time frame: 3, 6 and 12 months
Assess local resectability
Sensitivity and specificity for CT and MRI to assess local resectability for all patients that underwent surgery
Time frame: Baseline
One year survival
Survival rate after 1 year of follow-up
Time frame: Maximum 1 year
Median survival
Median survival time
Time frame: Maximum 1 year
Disease free survival
Time without (local) recurrence of cancer in patients that underwent resection
Time frame: Maximum 1 year
Progression free survival
Time without progression of cancer
Time frame: Maximum 1 year
Plan to share: Undecided
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Radboud University Medical Center