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| Name | Class |
|---|---|
| Dutch Cancer Society | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with (suspected) PDAC | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contrast-enhanced Diffusion-weighted MRI | Diagnostic Test | An MRI scan enhanced with intravenous contrast and with diffusion imaging at several B-values |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| One year survival | Survival rate after 1 year of follow-up | Maximum 1 year |
| Median survival | Median survival time | Maximum 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Geke Litjens, MD | Contact | +31243668392 | g.litjens@radboudumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Konstantopouleio general hospital | Recruiting | Athens | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32778061 | Derived | Litjens G, Riviere DM, van Geenen EJM, Radema SA, Brosens LAA, Prokop M, van Laarhoven CJHM, Hermans JJ. Diagnostic accuracy of contrast-enhanced diffusion-weighted MRI for liver metastases of pancreatic cancer: towards adequate staging and follow-up of pancreatic cancer - DIA-PANC study: study protocol for an international, multicenter, diagnostic trial. BMC Cancer. 2020 Aug 10;20(1):744. doi: 10.1186/s12885-020-07226-0. |
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International multicenter prospective cohort study
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Sensitivity and specificity for CT and MRI to assess local resectability for all patients that underwent surgery |
| Baseline |
| Disease free survival | Time without (local) recurrence of cancer in patients that underwent resection | Maximum 1 year |
| Progression free survival | Time without progression of cancer | Maximum 1 year |
| Radboudumc | Recruiting | Nijmegen | Gelderland | 6525GA | Netherlands |
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| Jeroen Bosch Ziekenhuis | Recruiting | 's-Hertogenbosch | 5223 GZ | Netherlands |
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| Medisch Spectrum Twente | Recruiting | Enschede | 7512KZ | Netherlands |
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| Universitair Medisch Centrum Groningen | Recruiting | Groningen | Netherlands |
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| Hospital Universitario Ramón y Cajal | Recruiting | Madrid | Spain |
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| Inselspital | Recruiting | Bern | Switzerland |
|
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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