Clinical trial NCT05428358: Incremental Value of Magnetic Resonance Imaging in Selection of Pancreatic Cancer Patients for Surgery
Official title: Incremental Value of Magnetic Resonance Imaging in Selection of Pancreatic Cancer Patients for Surgery (MAGIPAC): A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pancreatic Cancer
Pancreatic Neoplasm
Liver Metastases
Keywords: magnetic resonance imaging
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
name: Odense University Hospital
name: Aalborg University Hospital
First posted: 2022-06-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

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.

Primary outcomes:
measure: Change in treatment strategy
timeFrame: 1 week
Secondary outcomes:
measure: Liver metastases
timeFrame: 1 week
measure: Surgery
timeFrame: 1 month
measure: Resection
timeFrame: 1 month
measure: Intraoperatively detected liver metastases
timeFrame: 1 month
measure: Overall survival (1-year)
timeFrame: 1 year
measure: Overall survival (3-year)
timeFrame: 3 years
measure: Recurrence-free survival
timeFrame: 3 years
measure: Healthcare costs
timeFrame: 3 years
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Frank Mortensen, MD, DMSc
role: STUDY_CHAIR
affiliation: Aarhus University Hospital
name: Jakob Kirkegård, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: