NCT03469726

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
465

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2017

Longer than P75 for not_applicable

Geographic Reach
4 countries

7 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 22, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 19, 2018

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

September 21, 2021

Status Verified

October 1, 2020

Enrollment Period

4 years

First QC Date

February 28, 2018

Last Update Submit

September 19, 2021

Conditions

Pancreatic Neoplasms

Keywords

Liver metastasesDiffusion weighted MRI

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Detection of metastasis on CE-DW-MRI in follow-up (3, 6 and 12 months after baseline)

    3, 6 and 12 months

  • Assess local resectability

    Baseline

Other Outcomes (4)

  • One year survival

    Maximum 1 year

  • Median survival

    Maximum 1 year

  • Disease free survival

    Maximum 1 year

  • +1 more other outcomes

Study Arms (1)

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.

Diagnostic Test: Contrast-enhanced Diffusion-weighted MRI

Interventions

Contrast-enhanced Diffusion-weighted MRIDIAGNOSTIC_TEST

An MRI scan enhanced with intravenous contrast and with diffusion imaging at several B-values

Patients with (suspected) PDAC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Konstantopouleio general hospital

Athens, Greece

RECRUITING

Radboudumc

Nijmegen, Gelderland, 6525GA, Netherlands

RECRUITING

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, 5223 GZ, Netherlands

RECRUITING

Medisch Spectrum Twente

Enschede, 7512KZ, Netherlands

RECRUITING

Universitair Medisch Centrum Groningen

Groningen, Netherlands

RECRUITING

Hospital Universitario Ramón y Cajal

Madrid, Spain

RECRUITING

Inselspital

Bern, Switzerland

RECRUITING

Related Publications (1)

  • 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.

    PMID: 32778061DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • 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

Central Study Contacts

Geke Litjens, MD

CONTACT

+31243668392g.litjens@radboudumc.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: International multicenter prospective cohort study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2018

First Posted

March 19, 2018

Study Start

December 22, 2017

Primary Completion

January 1, 2022

Study Completion

January 1, 2023

Last Updated

September 21, 2021

Record last verified: 2020-10

Locations

GR(1)NL(4)CH(1)ES(1)