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

Primary Purpose

Pancreatic Cancer, Pancreatic Neoplasm, Liver Metastases

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Preoperative MRI
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pancreatic Cancer focused on measuring magnetic resonance imaging

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Pancreatic cancer patients considered to have a locally resectable tumor by the local hepato-pancreato-biliary tumor board
  • No liver metastases on CT
  • At least 18 years old and able to provide informed consent

Exclusion Criteria:

  • Extrahepatic disease (e.g. lung metastases)
  • 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 area; claustrophobia; cardiac pacemaker)

Sites / Locations

  • Aalborg University Hospital
  • Aarhus University HospitalRecruiting
  • RigshospitaletRecruiting
  • Odense University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Preoperative MRI

Arm Description

MRI before surgery.

Outcomes

Primary Outcome Measures

Change in treatment strategy
Change in treatment strategy from intended curative resection to other treatment based on MRI scan

Secondary Outcome Measures

Liver metastases
Proportion of patients who had liver metastases detected on MRI
Surgery
Proportion of patients who made it to surgery/exploration
Resection
Proportion of patients in each arm who had a pancreatic resection performed
Intraoperatively detected liver metastases
Proportion of patients with intraoperatively detected liver metastases not seen on either CT or MRI.
Overall survival (1-year)
1-year overall survival.
Overall survival (3-year)
3-year overall survival.
Recurrence-free survival
Recurrence-free survival according to final treatment strategy.
Healthcare costs
Healthcare costs in patients with change of treatment.

Full Information

First Posted
June 16, 2022
Last Updated
April 11, 2023
Sponsor
University of Aarhus
Collaborators
Rigshospitalet, Denmark, Odense University Hospital, Aalborg University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05428358
Brief Title
Incremental Value of Magnetic Resonance Imaging in Selection of Pancreatic Cancer Patients for Surgery
Acronym
MAGIPAC
Official Title
Incremental Value of Magnetic Resonance Imaging in Selection of Pancreatic Cancer Patients for Surgery (MAGIPAC): A Randomized Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 30, 2022 (Actual)
Primary Completion Date
September 1, 2025 (Anticipated)
Study Completion Date
September 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Rigshospitalet, Denmark, Odense University Hospital, Aalborg University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer, Pancreatic Neoplasm, Liver Metastases
Keywords
magnetic resonance imaging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Preoperative MRI
Arm Type
Experimental
Arm Description
MRI before surgery.
Intervention Type
Diagnostic Test
Intervention Name(s)
Preoperative MRI
Intervention Description
Preoperative MRI performed between outpatient visit at the surgical clinic and scheduled date of resection
Primary Outcome Measure Information:
Title
Change in treatment strategy
Description
Change in treatment strategy from intended curative resection to other treatment based on MRI scan
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Liver metastases
Description
Proportion of patients who had liver metastases detected on MRI
Time Frame
1 week
Title
Surgery
Description
Proportion of patients who made it to surgery/exploration
Time Frame
1 month
Title
Resection
Description
Proportion of patients in each arm who had a pancreatic resection performed
Time Frame
1 month
Title
Intraoperatively detected liver metastases
Description
Proportion of patients with intraoperatively detected liver metastases not seen on either CT or MRI.
Time Frame
1 month
Title
Overall survival (1-year)
Description
1-year overall survival.
Time Frame
1 year
Title
Overall survival (3-year)
Description
3-year overall survival.
Time Frame
3 years
Title
Recurrence-free survival
Description
Recurrence-free survival according to final treatment strategy.
Time Frame
3 years
Title
Healthcare costs
Description
Healthcare costs in patients with change of treatment.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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. MR performed during standard workup.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jakob Kirkegård, MD, PhD
Phone
+4522900604
Email
jakob.kirkegaard@auh.rm.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Frank Mortensen, MD, DMSc
Phone
+45222517296
Email
frmort@rm.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Mortensen, MD, DMSc
Organizational Affiliation
Aarhus University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jakob Kirkegård, MD, PhD
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aalborg University Hospital
City
Aalborg
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mogens Sall, MD
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jakob Kirkegård, MD, PhD
Phone
+4522900604
Email
jakob.kirkegaard@auh.rm.dk
First Name & Middle Initial & Last Name & Degree
Frank V Mortensen, MD, DMSc
Phone
+45222517296
Email
frmort@rm.dk
First Name & Middle Initial & Last Name & Degree
Jakob Kirkegård, MD, PhD
First Name & Middle Initial & Last Name & Degree
Frank V Mortensen, MD, DMSc
Facility Name
Rigshospitalet
City
Copenhagen
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carsten P Hansen, MD, DMSc
Facility Name
Odense University Hospital
City
Odense
Country
Denmark
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Due to Danish law, no individual-level data can be shared.

Learn more about this trial

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

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