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Magnetic Resonance Imaging for Better Selection of Pancreatic Cancer Patients for Surgery: A Randomized Clinical Trial (MAGIPAC)

Primary Purpose

Pancreas Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MRI scan
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pancreas Cancer focused on measuring Magnetic Resonance Imaging (MRi), Computed Tomography (CT)

Eligibility Criteria

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

Inclusion Criteria:

  • Must be eligible for curative pancreatic resection based on CT
  • Must accept randomization

Exclusion Criteria:

  • Not eligible for curative pancreatic resection
  • Unable to undergo MRI.
  • Did not accept randomization.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Other

    Arm Label

    Conventional

    MRI scan

    Arm Description

    Patients who are eligible for surgery are randomized to MRI scan or standard curative surgery. Patients in this arm will receive standard care according to danish standards without pre-operative MRI scans.

    This arm includes patients who have been randomized to pre-operative MRI scans.

    Outcomes

    Primary Outcome Measures

    Correlation in tumor staging (T- and N-stage) between CT and MR
    The degree of correlation between CT and MR with respect to T- and N-stage. Will be assessed using Kappa-values.
    Proportion of patients with liver metastases in the intervention arm
    To examine if MRI scans identify more metastases than conventional CT scans. Measured by the Chi2-test.
    One-year survival after randomization
    To examine if MRI scans improves survival of patients with pancreatic cancer.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 1, 2022
    Last Updated
    March 15, 2022
    Sponsor
    University of Aarhus
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05253313
    Brief Title
    Magnetic Resonance Imaging for Better Selection of Pancreatic Cancer Patients for Surgery: A Randomized Clinical Trial
    Acronym
    MAGIPAC
    Official Title
    Magnetic Resonance Imaging for Better Selection of Pancreatic Cancer Patients for Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 1, 2022 (Anticipated)
    Primary Completion Date
    August 31, 2023 (Anticipated)
    Study Completion Date
    August 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Aarhus

    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
    Pancreatic cancer has the most dismal prognosis with a 5-year survival of 8%. The only curative treatment is surgery which is accompanied by great morbidity and mortality. Recent research indicates that Magnetic Resonance Imaging (MRI) is superior in detecting liver metastases compared with today's gold standard computed tomography (CT), which usually is a contraindication to surgery. Investigators want to randomize patients with pancreatic cancer, who are eligible for surgery to a pre-operative MRI. The investigators want to examine if MRI is as good for the staging as CT and if MRI is better for the identification of liver metastases. Patients will have a follow-up period of 1 year to see if MRI changes the overall survival.
    Detailed Description
    Currently, CT is the state of art for assessing and staging pancreatic cancer. However, it has its limitations when it comes to detecting small liver metastases, which are often found in pancreatic cancer. Recent research indicates that MRI is superior to CT when it comes to the detection of liver metastases. Thus, the investigators want to examine MRI's role in the assessment of pancreatic cancer. The investigators want to conduct a nationwide RCT to examine the feasibility of using MRI for tumor staging and identification. The overall aim is to improve the selection of patients going to surgery so futile resections are avoided and increase the overall survival. Patients who are deemed eligible for pancreatic resection after being reviewed at a local multidisciplinary tumor board will be, upon consent, electronically randomized to one of two treatment arms (each arm will contain 100 patients). Patients within the control arm will as per usual proceed to surgery, whereas patients in the intervention arm will receive a pre-operative MRI scan. The MRI will be read by experienced gastroenterology radiologists who are blinded to the patient's identity and the initial CT findings. Treatment will be based on MRI findings. There will be a follow-up period of 1 year to see if MRI changes the overall survival. Within this RCT we will conduct three studies. Study 1) The investigators want to compare pancreatic tumor staging with MRI versus standard upper abdominal CT, we hypothesize that MRI is not inferior to CT. Study 2) The investigators want to assess MRI's ability to detect liver metastases vs standard upper abdominal CT, in patients otherwise deemed eligible for surgery. We hypothesize that MRI is superior to CT in the detection of liver metastases. Study 3) The investigators want to assess the impact of MRI, thus patients will be followed for 1 year. We want to see if MRI changes the overall survival, treatment allocation, and recurrence.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pancreas Cancer
    Keywords
    Magnetic Resonance Imaging (MRi), Computed Tomography (CT)

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Conventional
    Arm Type
    No Intervention
    Arm Description
    Patients who are eligible for surgery are randomized to MRI scan or standard curative surgery. Patients in this arm will receive standard care according to danish standards without pre-operative MRI scans.
    Arm Title
    MRI scan
    Arm Type
    Other
    Arm Description
    This arm includes patients who have been randomized to pre-operative MRI scans.
    Intervention Type
    Other
    Intervention Name(s)
    MRI scan
    Intervention Description
    Patients will be randomized to a pre-operative scan or not. The MRI scan will evaluate the local extent of the tumor and especially focus on identifying possible liver metastases unseen on the CT-scan.
    Primary Outcome Measure Information:
    Title
    Correlation in tumor staging (T- and N-stage) between CT and MR
    Description
    The degree of correlation between CT and MR with respect to T- and N-stage. Will be assessed using Kappa-values.
    Time Frame
    1 year
    Title
    Proportion of patients with liver metastases in the intervention arm
    Description
    To examine if MRI scans identify more metastases than conventional CT scans. Measured by the Chi2-test.
    Time Frame
    1 year
    Title
    One-year survival after randomization
    Description
    To examine if MRI scans improves survival of patients with pancreatic cancer.
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Must be eligible for curative pancreatic resection based on CT Must accept randomization Exclusion Criteria: Not eligible for curative pancreatic resection Unable to undergo MRI. Did not accept randomization.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Christian Flindt Nielsen., Cand. med.
    Phone
    +4551530041
    Email
    Cflindtn@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jakob Kirkegaard, PhD
    Phone
    +4522900604
    Email
    jakob.kirkegaard@auh.rm.dk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Frank Viborg Mortensen, Prof.
    Organizational Affiliation
    Professor MTK AUh
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Magnetic Resonance Imaging for Better Selection of Pancreatic Cancer Patients for Surgery: A Randomized Clinical Trial

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