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Recruiting NCT05428358

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

No phase Interventional Pancreatic Cancer Pancreatic Neoplasm Liver Metastases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Preoperative MRI.
Who it may be relevant to
Registry conditions: Pancreatic Cancer, Pancreatic Neoplasm, Liver Metastases. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Incremental Value of Magnetic Resonance Imaging in Selection of Pancreatic Cancer Patients for Surgery (MAGIPAC): A Randomized Clinical Trial.

Overview

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.

Detailed description

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.

Interventions

  • Diagnostic test Preoperative MRI
    Preoperative MRI performed between outpatient visit at the surgical clinic and scheduled date of resection

Primary outcome measures

  • Change in treatment strategy [Time frame: 1 week]
Secondary outcome measures (8)
  • Liver metastases [Time frame: 1 week]
  • Surgery [Time frame: 1 month]
  • Resection [Time frame: 1 month]
  • Intraoperatively detected liver metastases [Time frame: 1 month]
  • Overall survival (1-year) [Time frame: 1 year]
  • Overall survival (3-year) [Time frame: 3 years]
  • Recurrence-free survival [Time frame: 3 years]
  • Healthcare costs [Time frame: 3 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Denmark · 3 centers
  • Aalborg University Hospital — Aalborg
  • Aarhus University Hospital — Aarhus
  • Rigshospitalet — Copenhagen

Identifiers

NCT: NCT05428358 · MAGIPAC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗