Contrast-enhanced Diffusion-weighted MRI to Detect Liver Metastases in Patients With Pancreatic Cancer (DIA-PANC)
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|ClinicalTrials.gov Identifier: NCT03469726|
Recruitment Status : Recruiting
First Posted : March 19, 2018
Last Update Posted : April 1, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Neoplasms||Diagnostic Test: Contrast-enhanced Diffusion-weighted MRI||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||465 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||International multicenter prospective cohort study|
|Masking:||None (Open Label)|
|Official Title:||Diagnostic Accuracy of Contrast-enhanced Diffusion-weighted MRI for Liver Metastases of Pancreatic Cancer: Towards Adequate Staging and Follow-up of Pancreatic Cancer|
|Actual Study Start Date :||December 22, 2017|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Patients with (suspected) PDAC
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 [ Time Frame: Baseline ]Sensitivity and Specificity of CE-DW-MRI for the detection of liver metastases in patients with pancreatic cancer compared to CECT.
- Detection of metastasis on CE-DW-MRI in follow-up (3, 6 and 12 months after baseline) [ Time Frame: 3, 6 and 12 months ]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
- Assess local resectability [ Time Frame: Baseline ]Sensitivity and specificity for CT and MRI to assess local resectability for all patients that underwent surgery
- One year survival [ Time Frame: Maximum 1 year ]Survival rate after 1 year of follow-up
- Median survival [ Time Frame: Maximum 1 year ]Median survival time
- Disease free survival [ Time Frame: Maximum 1 year ]Time without (local) recurrence of cancer in patients that underwent resection
- Progression free survival [ Time Frame: Maximum 1 year ]Time without progression of cancer
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03469726
|Contact: Geke Litjens, MDfirstname.lastname@example.org|
|Konstantopouleio general hospital||Recruiting|
|Contact: Charikleia Triantopoulou, MD, PhD|
|Nijmegen, Gelderland, Netherlands, 6525GA|
|Contact: Geke Litjens, MD +31243668392 email@example.com|
|Medisch Spectrum Twente||Not yet recruiting|
|Enschede, Netherlands, 7512KZ|
|Contact: Niels G Venneman, MD, PhD|
|Principal Investigator:||John J. Hermans, dr. ir.||Radboudumc, Department of Radiology and Nuclear Medicine|
|Principal Investigator:||Kees C.J.H.M. van Laarhoven, prof. dr.||Radboudumc, Department of Surgery|