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

NCT05253313 | Unknown

• 1 other identifier: 22552255
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pancreas Cancer

Keywords

Magnetic Resonance Imaging (MRi); Computed Tomography (CT)

Outcome Measures

Primary Outcomes (3)

• 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.

  1 year

• 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.

  1 year

• One-year survival after randomization

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

  1 year

Study Arms (2)

Conventional

NO INTERVENTION

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.

MRI scan

OTHER

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

Other: MRI scan

Interventions

MRI scan OTHER

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.

MRI scan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be eligible for curative pancreatic resection based on CT
• Must accept randomization

You may not qualify if:

• Not eligible for curative pancreatic resection
• Unable to undergo MRI.
• Did not accept randomization.

Sponsors & Collaborators

• University of Aarhus: lead

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Frank Viborg Mortensen, Prof.

  Professor MTK AUh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian Flindt Nielsen., Cand. med.

CONTACT

+4551530041; Cflindtn@gmail.com

Jakob Kirkegaard, PhD

CONTACT

+4522900604; jakob.kirkegaard@auh.rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2022
• First Posted: February 23, 2022
• Study Start: May 1, 2022
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2024
• Last Updated: March 16, 2022

Record last verified: 2022-01