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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05428358
Other study ID # MAGIPAC
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 30, 2022
Est. completion date September 1, 2027

Study information

Verified date November 2023
Source University of Aarhus
Contact Jakob Kirkegård, MD, PhD
Phone +4522900604
Email jakob.kirkegaard@auh.rm.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date September 1, 2027
Est. primary completion date September 1, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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 Design


Intervention

Diagnostic Test:
Preoperative MRI
Preoperative MRI performed between outpatient visit at the surgical clinic and scheduled date of resection

Locations

Country Name City State
Denmark Aalborg University Hospital Aalborg
Denmark Aarhus University Hospital Aarhus
Denmark Rigshospitalet Copenhagen
Denmark Odense University Hospital Odense

Sponsors (4)

Lead Sponsor Collaborator
University of Aarhus Aalborg University Hospital, Odense University Hospital, Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in treatment strategy Change in treatment strategy from intended curative resection to other treatment based on MRI scan 1 week
Secondary Liver metastases Proportion of patients who had liver metastases detected on MRI 1 week
Secondary Surgery Proportion of patients who made it to surgery/exploration 1 month
Secondary Resection Proportion of patients in each arm who had a pancreatic resection performed 1 month
Secondary Intraoperatively detected liver metastases Proportion of patients with intraoperatively detected liver metastases not seen on either CT or MRI. 1 month
Secondary Overall survival (1-year) 1-year overall survival. 1 year
Secondary Overall survival (3-year) 3-year overall survival. 3 years
Secondary Recurrence-free survival Recurrence-free survival according to final treatment strategy. 3 years
Secondary Healthcare costs Healthcare costs in patients with change of treatment. 3 years
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