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

Not Applicable

• Conditions: Pancreatic Neoplasms
• Interventions: Diagnostic Test: Contrast-enhanced Diffusion-weighted MRI

• Registration Number: NCT03469726
• Lead Sponsor: Radboud University Medical Center

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-12-22
• Study First Submitted: 2018-02-28
• Study First Submitted QC: 2018-03-12
• Study First Posted: 2018-03-19
• Status Verified: 2020-10
• Last Update Submitted: 2021-09-19
• Last Update Posted: 2021-09-21
• Primary Completion: 2022-01-01
• Study Completion: 2023-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 465

Inclusion Criteria

• 18 years and older
• clinical suspicion of pancreatic cancer
• written (signed and dated) informed consent

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with (suspected) PDAC	Contrast-enhanced Diffusion-weighted MRI	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.

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of CE-DW-MRI	Baseline	Sensitivity and Specificity of CE-DW-MRI for the detection of liver metastases in patients with pancreatic cancer compared to CECT.

Secondary Outcome Measures

Name	Time	Method
Detection of metastasis on CE-DW-MRI in follow-up (3, 6 and 12 months after baseline)	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	Baseline	Sensitivity and specificity for CT and MRI to assess local resectability for all patients that underwent surgery

Trial Locations

Locations (7)

Radboudumc; 🇳🇱 Nijmegen, Gelderland, Netherlands

Jeroen Bosch Ziekenhuis; 🇳🇱 Den Bosch, Netherlands

Medisch Spectrum Twente; 🇳🇱 Enschede, Netherlands

Universitair Medisch Centrum Groningen; 🇳🇱 Groningen, Netherlands

Inselspital; 🇨🇭 Bern, Switzerland

Konstantopouleio general hospital; 🇬🇷 Athens, Greece

Hospital Universitario Ramón y Cajal; 🇪🇸 Madrid, Spain