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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pancreatic Cancer, Pancreatic Neoplasm, Liver Metastases

Intervention / Treatment
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* Diagnostic Test: Preoperative MRI


Participation Criteria
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Eligibility Criteria
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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. MR performed during standard workup.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preoperative MRI<br>MRI before surgery. | Diagnostic Test: Preoperative MRI<br>* Preoperative MRI performed between outpatient visit at the surgical clinic and scheduled date of resection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in treatment strategy | Change in treatment strategy from intended curative resection to other treatment based on MRI scan | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver metastases | Proportion of patients who had liver metastases detected on MRI | 1 week | 
| Surgery | Proportion of patients who made it to surgery/exploration | 1 month | 
| Resection | Proportion of patients in each arm who had a pancreatic resection performed | 1 month | 
| Intraoperatively detected liver metastases | Proportion 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 survival | Recurrence-free survival according to final treatment strategy. | 3 years | 
| Healthcare costs | Healthcare costs in patients with change of treatment. | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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magnetic resonance imaging