Contrast-enhanced Diffusion-weighted MRI to Detect Liver Metastases in Patients With Pancreatic Cancer
NCT ID: NCT03469726
Last Updated: 2021-09-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
465 participants
INTERVENTIONAL
2017-12-22
2023-01-01
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
Contrast-enhanced Diffusion-weighted MRI
An MRI scan enhanced with intravenous contrast and with diffusion imaging at several B-values
Interventions
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Contrast-enhanced Diffusion-weighted MRI
An MRI scan enhanced with intravenous contrast and with diffusion imaging at several B-values
Eligibility Criteria
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Inclusion Criteria
* clinical suspicion of pancreatic cancer
* written (signed and dated) informed consent
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Dutch Cancer Society
OTHER
Radboud University Medical Center
OTHER
Responsible Party
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Principal Investigators
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John J. Hermans, dr. ir.
Role: PRINCIPAL_INVESTIGATOR
Radboudumc, Department of Radiology and Nuclear Medicine
Kees C.J.H.M. van Laarhoven, prof. dr.
Role: PRINCIPAL_INVESTIGATOR
Radboudumc, Department of Surgery
Locations
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Konstantopouleio general hospital
Athens, , Greece
Radboudumc
Nijmegen, Gelderland, Netherlands
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, , Netherlands
Medisch Spectrum Twente
Enschede, , Netherlands
Universitair Medisch Centrum Groningen
Groningen, , Netherlands
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Inselspital
Bern, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Charikleia Triantopoulou, MD, PhD
Role: primary
Koop Bosscha, MD, PhD
Role: primary
Niels G Venneman, MD, PhD
Role: primary
Koert de Jong, MD, PhD
Role: primary
Julie Earl, PhD
Role: primary
Adrian Huber, MD, PhD
Role: primary
References
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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.
Other Identifiers
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NL60473.091.17
Identifier Type: -
Identifier Source: org_study_id
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