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

Pancreatic Cancer Clinical Trial

— MAGIPAC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05428358
• Other study ID #: MAGIPAC
• Status: Recruiting
• Phase: N/A
• Start date: August 30, 2022
• Est. completion date: September 1, 2027

Study information

• Verified date: November 2023
• Source: University of Aarhus
• Contact: Jakob Kirkegård, MD, PhD
• Phone: +4522900604
• Email: jakob.kirkegaard[@]auh.rm.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 1, 2027
• Est. primary completion date: September 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Liver Metastases
• Pancreatic Cancer
• Pancreatic Neoplasm
• Pancreatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg
Denmark	Aarhus University Hospital	Aarhus
Denmark	Rigshospitalet	Copenhagen
Denmark	Odense University Hospital	Odense

Sponsors (4)

Lead Sponsor	Collaborator
University of Aarhus	Aalborg University Hospital, Odense University Hospital, Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in treatment strategy	Change in treatment strategy from intended curative resection to other treatment based on MRI scan	1 week
Secondary	Liver metastases	Proportion of patients who had liver metastases detected on MRI	1 week
Secondary	Surgery	Proportion of patients who made it to surgery/exploration	1 month
Secondary	Resection	Proportion of patients in each arm who had a pancreatic resection performed	1 month
Secondary	Intraoperatively detected liver metastases	Proportion of patients with intraoperatively detected liver metastases not seen on either CT or MRI.	1 month
Secondary	Overall survival (1-year)	1-year overall survival.	1 year
Secondary	Overall survival (3-year)	3-year overall survival.	3 years
Secondary	Recurrence-free survival	Recurrence-free survival according to final treatment strategy.	3 years
Secondary	Healthcare costs	Healthcare costs in patients with change of treatment.	3 years