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

Sponsor
University of Aarhus (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05253313
Collaborator
(none)
200
2
28

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: MRI scan
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Diagnostic
Official Title:
Magnetic Resonance Imaging for Better Selection of Pancreatic Cancer Patients for Surgery
Anticipated Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
Aug 31, 2023
Anticipated Study Completion Date :
Aug 31, 2024

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Conventional

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.

Other: MRI scan

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

Other: MRI scan
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.

Outcome Measures

Primary Outcome Measures

  1. Correlation in tumor staging (T- and N-stage) between CT and MR [1 year]

    The degree of correlation between CT and MR with respect to T- and N-stage. Will be assessed using Kappa-values.

  2. Proportion of patients with liver metastases in the intervention arm [1 year]

    To examine if MRI scans identify more metastases than conventional CT scans. Measured by the Chi2-test.

  3. One-year survival after randomization [1 year]

    To examine if MRI scans improves survival of patients with pancreatic cancer.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Aarhus

Investigators

  • Principal Investigator: Frank Viborg Mortensen, Prof., Professor MTK AUh

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT05253313
Other Study ID Numbers:
  • 22552255
First Posted:
Feb 23, 2022
Last Update Posted:
Mar 16, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Aarhus
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 16, 2022