NCT05428358

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable pancreatic-cancer

Timeline
31mo left

Started Aug 2022

Longer than P75 for not_applicable pancreatic-cancer

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
Aug 2022Dec 2028

First Submitted

Initial submission to the registry

June 16, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 23, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

August 30, 2022

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

5.3 years

First QC Date

June 16, 2022

Last Update Submit

April 28, 2026

Conditions

Keywords

magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

  • Change in treatment strategy

    Change in treatment strategy from intended curative resection to other treatment based on MRI scan

    1 week

Secondary Outcomes (8)

  • Liver metastases

    1 week

  • Surgery

    1 month

  • Resection

    1 month

  • Intraoperatively detected liver metastases

    1 month

  • Overall survival (1-year)

    1 year

  • +3 more secondary outcomes

Study Arms (1)

Preoperative MRI

EXPERIMENTAL

MRI before surgery.

Diagnostic Test: Preoperative MRI

Interventions

Preoperative MRIDIAGNOSTIC_TEST

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

Preoperative MRI

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Aalborg University Hospital

Aalborg, Denmark

RECRUITING

Aarhus University Hospital

Aarhus, 8200, Denmark

RECRUITING

Rigshospitalet

Copenhagen, Denmark

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Frank Mortensen, MD, DMSc

    Aarhus University Hospital

    STUDY CHAIR
  • Jakob Kirkegård, MD, PhD

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jakob Kirkegård, MD, PhD

CONTACT

Frank Mortensen, MD, DMSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2022

First Posted

June 23, 2022

Study Start

August 30, 2022

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2028

Last Updated

April 29, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Due to Danish law, no individual-level data can be shared.

Locations