Incremental Value of Magnetic Resonance Imaging in Selection of Pancreatic Cancer Patients for Surgery (MAGIPAC)
Incremental Value of Magnetic Resonance Imaging in Selection of Pancreatic Cancer Patients for Surgery (MAGIPAC): A Randomized Clinical Trial.
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Jakob Kirkegård, MD, PhD
- Phone Number: +4522900604
- Email: jakob.kirkegaard@auh.rm.dk
Study Contact Backup
- Name: Frank Mortensen, MD, DMSc
- Phone Number: +45222517296
- Email: frmort@rm.dk
Study Locations
-
-
-
Aalborg, Denmark
- Recruiting
- Aalborg University Hospital
-
Contact:
- Mogens Stender, MD, PhD
-
Aarhus, Denmark, 8200
- Recruiting
- Aarhus University Hospital
-
Contact:
- Jakob Kirkegård, MD, PhD
- Phone Number: +4522900604
- Email: jakob.kirkegaard@auh.rm.dk
-
Contact:
- Frank V Mortensen, MD, DMSc
- Phone Number: +45222517296
- Email: frmort@rm.dk
-
Principal Investigator:
- Jakob Kirkegård, MD, PhD
-
Sub-Investigator:
- Frank V Mortensen, MD, DMSc
-
Copenhagen, Denmark
- Recruiting
- Rigshospitalet
-
Contact:
- Carsten P Hansen, MD, DMSc
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Preoperative MRI
MRI before surgery.
|
Preoperative MRI performed between outpatient visit at the surgical clinic and scheduled date of resection
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in treatment strategy
Time Frame: 1 week
|
Change in treatment strategy from intended curative resection to other treatment based on MRI scan
|
1 week
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Liver metastases
Time Frame: 1 week
|
Proportion of patients who had liver metastases detected on MRI
|
1 week
|
|
Surgery
Time Frame: 1 month
|
Proportion of patients who made it to surgery/exploration
|
1 month
|
|
Resection
Time Frame: 1 month
|
Proportion of patients in each arm who had a pancreatic resection performed
|
1 month
|
|
Intraoperatively detected liver metastases
Time Frame: 1 month
|
Proportion of patients with intraoperatively detected liver metastases not seen on either CT or MRI.
|
1 month
|
|
Overall survival (1-year)
Time Frame: 1 year
|
1-year overall survival.
|
1 year
|
|
Overall survival (3-year)
Time Frame: 3 years
|
3-year overall survival.
|
3 years
|
|
Recurrence-free survival
Time Frame: 3 years
|
Recurrence-free survival according to final treatment strategy.
|
3 years
|
|
Healthcare costs
Time Frame: 3 years
|
Healthcare costs in patients with change of treatment.
|
3 years
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Study Chair: Frank Mortensen, MD, DMSc, Aarhus University Hospital
- Principal Investigator: Jakob Kirkegård, MD, PhD, Aarhus University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- MAGIPAC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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