Clinical trial NCT03469726: Contrast-enhanced Diffusion-weighted MRI to Detect Liver Metastases in Patients With Pancreatic Cancer
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatic Neoplasms
Keywords: Liver metastases
Diffusion weighted MRI
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Dutch Cancer Society
First posted: 2018-03-19
Enrollment: 465
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: International multicenter prospective cohort study
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic accuracy of CE-DW-MRI
timeFrame: Baseline
Secondary outcomes:
measure: Detection of metastasis on CE-DW-MRI in follow-up (3, 6 and 12 months after baseline)
timeFrame: 3, 6 and 12 months
measure: Assess local resectability
timeFrame: Baseline
Other outcomes:
measure: One year survival
timeFrame: Maximum 1 year
measure: Median survival
timeFrame: Maximum 1 year
measure: Disease free survival
timeFrame: Maximum 1 year
measure: Progression free survival
timeFrame: Maximum 1 year
Locations:
city: Athens
country: Greece
facility: Konstantopouleio general hospital
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
city: Den Bosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Bern
country: Switzerland
facility: Inselspital
Study officials:
affiliation: Radboudumc, Department of Radiology and Nuclear Medicine
name: John J. Hermans, dr. ir.
role: PRINCIPAL_INVESTIGATOR
affiliation: Radboudumc, Department of Surgery
name: Kees C.J.H.M. van Laarhoven, prof. dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.