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Incremental Value of Magnetic Resonance Imaging in Selection of Pancreatic Cancer Patients for Surgery


2022-08-30


2027-12-01


2028-12-01


200

Study Overview

Incremental Value of Magnetic Resonance Imaging in Selection of Pancreatic Cancer Patients for Surgery

The aim of the study is to examine the incremental value of using magnetic resonance imaging (MRI) in addition to computed tomography (CT) in the diagnostic workup of pancreatic cancer patients.

The aim of the study is to examine the incremental value of using magnetic resonance imaging (MRI) in addition to computed tomography (CT) in the diagnostic workup of pancreatic cancer patients. We will conduct a nationwide, prospective clinical trial to examine the incremental value of using MRI for identification of liver metastases in pancreatic cancer patients.

  • Pancreatic Cancer
  • Pancreatic Neoplasm
  • Liver Metastases
  • DIAGNOSTIC_TEST: Preoperative MRI
  • MAGIPAC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2022-06-16  

N/A  

2025-03-26  

2022-06-16  

N/A  

2025-03-27  

2022-06-23  

N/A  

2025-03  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Diagnostic


Allocation:
Na


Interventional Model:
Single Group


Masking:
None


Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Preoperative MRI

MRI before surgery.

DIAGNOSTIC_TEST: Preoperative MRI

  • Preoperative MRI performed between outpatient visit at the surgical clinic and scheduled date of resection
Primary Outcome MeasuresMeasure DescriptionTime Frame
Change in treatment strategyChange in treatment strategy from intended curative resection to other treatment based on MRI scan1 week
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Liver metastasesProportion of patients who had liver metastases detected on MRI1 week
SurgeryProportion of patients who made it to surgery/exploration1 month
ResectionProportion of patients in each arm who had a pancreatic resection performed1 month
Intraoperatively detected liver metastasesProportion of patients with intraoperatively detected liver metastases not seen on either CT or MRI.1 month
Overall survival (1-year)1-year overall survival.1 year
Overall survival (3-year)3-year overall survival.3 years
Recurrence-free survivalRecurrence-free survival according to final treatment strategy.3 years
Healthcare costsHealthcare costs in patients with change of treatment.3 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Jakob Kirkegård, MD, PhD

Phone Number: +4522900604

Email: jakob.kirkegaard@auh.rm.dk

Study Contact Backup

Name: Frank Mortensen, MD, DMSc

Phone Number: +45222517296

Email: frmort@rm.dk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion criteria:

  • Pancreatic cancer patients considered to have a locally resectable or borderline resectable tumor by the local hepato-pancreato-biliary multidisciplinary team board
  • No liver metastases on CT
  • At least 18 years old and able to provide informed consent
  • Expected pancreatic ductal adenocarcinoma based on CT scan

  • Exclusion criteria:

  • Metastatic disease
  • Prior receipt of neoadjuvant chemotherapy or downstaging/-sizing treatment
  • Comorbidity rendering major surgery unfeasible (inoperable)
  • No informed consent
  • Unable to undergo MRI (Kidney insufficiency (eGFR < 60 ml/min/1.73 m2 body surface ar-ea); Claustrophobia; Cardiac pacemaker)
  • Postoperative histology other than adenocarcinoma of pancreato-biliary origin.
  • MRI with liver-specific contrast performed during standard workup.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

  • Rigshospitalet, Denmark
  • Odense University Hospital
  • Aalborg University Hospital

  • STUDY_CHAIR: Frank Mortensen, MD, DMSc, Aarhus University Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available