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

Pancreas Cancer Clinical Trial

— MAGIPAC  

Official title:

Magnetic Resonance Imaging for Better Selection of Pancreatic Cancer Patients for Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05253313
• Other study ID #: 22552255
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: August 31, 2024

Study information

• Verified date: January 2022
• Source: University of Aarhus
• Contact: Christian Flindt Nielsen., Cand. med.
• Phone: +4551530041
• Email: Cflindtn[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pancreas Cancer
• Pancreatic Neoplasms

Intervention

Other:
• MRI scan
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	One-year survival after randomization	To examine if MRI scans improves survival of patients with pancreatic cancer.	1 year