Contrast-enhanced Diffusion-weighted MRI to Detect Liver Metastases in Patients With Pancreatic Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Diagnostic Accuracy of Contrast-enhanced Diffusion-weighted MRI for Liver Metastases of Pancreatic Cancer: Towards Adequate Staging and Follow-up of Pancreatic Cancer

Conditions
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Pancreatic Neoplasms

Intervention / Treatment
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* Diagnostic Test: Contrast-enhanced Diffusion-weighted MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years and older clinical suspicion of pancreatic cancer written (signed and dated) informed consent Exclusion Criteria: previous treatment for pancreatic cancer (e.g. chemotherapy, radiotherapy, surgery, ablation therapy) concomitant malignancies, except for adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri. Subjects with prior malignancies must be disease-free for at least 5 years contra-indications to undergo CT (due to e.g. extreme claustrophobia, untreatable contrast allergy, renal function impairment) contra-indications to undergo MRI (due to e.g. claustrophobia, untreatable contrast allergy, or not MRI compatible medical devices) insufficient command of the Dutch language to be able to understand the patient information or fill in the questionnaires pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: International multicenter prospective cohort study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients with (suspected) PDAC<br>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<br>* An MRI scan enhanced with intravenous contrast and with diffusion imaging at several B-values<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver metastases, Diffusion weighted MRI