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