Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Contrast-enhanced Diffusion-weighted MRI to Detect Liver Metastases in Patients With Pancreatic Cancer (DIA-PANC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03469726
Recruitment Status : Recruiting
First Posted : March 19, 2018
Last Update Posted : April 1, 2019
Sponsor:
Collaborator:
Dutch Cancer Society
Information provided by (Responsible Party):
Radboud University

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.


Condition or disease Intervention/treatment Phase
Pancreatic Neoplasms Diagnostic Test: Contrast-enhanced Diffusion-weighted MRI Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 465 participants
Intervention Model: Single Group Assignment
Intervention Model Description: International multicenter prospective cohort study
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : December 22, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

Diagnostic Test: Contrast-enhanced Diffusion-weighted MRI
An MRI scan enhanced with intravenous contrast and with diffusion imaging at several B-values




Primary Outcome Measures :
  1. Diagnostic accuracy of CE-DW-MRI [ Time Frame: 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 :
  1. Detection of metastasis on CE-DW-MRI in follow-up (3, 6 and 12 months after baseline) [ Time Frame: 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

  2. Assess local resectability [ Time Frame: Baseline ]
    Sensitivity and specificity for CT and MRI to assess local resectability for all patients that underwent surgery


Other Outcome Measures:
  1. One year survival [ Time Frame: Maximum 1 year ]
    Survival rate after 1 year of follow-up

  2. Median survival [ Time Frame: Maximum 1 year ]
    Median survival time

  3. Disease free survival [ Time Frame: Maximum 1 year ]
    Time without (local) recurrence of cancer in patients that underwent resection

  4. Progression free survival [ Time Frame: Maximum 1 year ]
    Time without progression of cancer



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03469726


Contacts
Layout table for location contacts
Contact: Geke Litjens, MD +31243668392 g.litjens@radboudumc.nl

Locations
Layout table for location information
Greece
Konstantopouleio general hospital Recruiting
Athens, Greece
Contact: Charikleia Triantopoulou, MD, PhD         
Netherlands
Radboudumc Recruiting
Nijmegen, Gelderland, Netherlands, 6525GA
Contact: Geke Litjens, MD    +31243668392    g.litjens@radboudumc.nl   
Medisch Spectrum Twente Not yet recruiting
Enschede, Netherlands, 7512KZ
Contact: Niels G Venneman, MD, PhD         
Sponsors and Collaborators
Radboud University
Dutch Cancer Society
Investigators
Layout table for investigator information
Principal Investigator: 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

Layout table for additonal information
Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT03469726     History of Changes
Other Study ID Numbers: NL60473.091.17
First Posted: March 19, 2018    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Radboud University:
Liver metastases
Diffusion weighted MRI
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasm Metastasis
Pancreatic Neoplasms
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Pancreatic Diseases
Body Weight
Neoplastic Processes
Pathologic Processes
Digestive System Diseases
Endocrine System Diseases
Signs and Symptoms
Liver Extracts
Hematinics