PRetreatment MRI for OCcult Liver Metastasis Assessment In Pancreatic Ductal adenocarcinoMa

NCT07252076 | Recruiting

• 1 other identifier: ASO.ChirGen.25.03
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Pancreatic cancer has a low survival rate largely due to late diagnosis and undetected liver metastases. Computed tomography (CT), the standard diagnostic tool, often misses occult metastases that are later discovered during surgery. Recent studies suggest that magnetic resonance imaging (MRI), especially with diffusion-weighted imaging (DWI), can better detect very small liver metastases and help avoid unnecessary surgery. However, MRI is not yet widely used in routine practice due to limited evidence and its selective application. This study proposes incorporating contrast-enhanced MRI and DWI into the diagnostic workflow to improve diagnostic accuracy and guide more effective treatment decisions for patients with pancreatic cancer.

Conditions

Pancreatic Ductal Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Percentage of patients

  Percentage of patients in whom MEOs will be detected on MRI in the intention-to-image population after negative CT for secondary lesions.

  Through study completion, an average of 18 months

Secondary Outcomes (1)

• Identification of the target sequences

  Through study completion, an average of 18 months

Other Outcomes (1)

• Predictive model creation

  Through study completion, an average of 18 months

Interventions

Contrast-enhanced MRI and DWI sequences RADIATION

Assessment of the accuracy of contrast-enhanced MRI and DWI sequences in detecting liver metastases in PDAC that are not identified on CT and evaluation of the clinical impact of adding this imaging modality to the diagnostic algorithm in this specific patient population.

Eligibility Criteria

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

Study Population

Patients who have received a histopathological diagnosis of pancreatic ductal adenocarcinoma and have undergone contrast-enhanced CT without evidence of metastatic disease, defined as the presence of suspicious lesions in the liver, lungs, distant lymph nodes, peritoneum, or other organs.

You may qualify if:

• Male or female patients over 18 years of age.
• Patients with a new cytological or histological diagnosis of PDAC.
• A CT scan demonstrating pancreatic disease and meeting the minimum criteria for the imaging assessment of pancreatic gland tumors (see section 4.6, study procedures).
• An MRI performed no later than 3 weeks after the CT scan, also meeting the minimum radiological criteria (see section 4.6, study procedures).
• No prior treatment for pancreatic disease.
• Patients able to receive and understand the study information and to provide written informed consent duly signed by both the patient and the investigator.

You may not qualify if:

• Signs of metastatic disease on the initial CT scan (hepatic, pulmonary, distant lymph node, peritoneal carcinomatosis, or other organ involvement).

Sponsors & Collaborators

• Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria: lead

Study Sites (1)

SC Chirurgia Generale

Alessandria, Piedmont, 15121, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

A blood sample will be taken from patients included in the study and stored prior to surgery for possible future investigations into biological markers.

Central Study Contacts

Clinical Trial Center Clinical Trial Center

CONTACT

0131206893; clinicaltrialcenter@ospedale.al.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 26, 2025
• Study Start: July 17, 2025
• Primary Completion (Estimated): December 17, 2026
• Study Completion (Estimated): January 17, 2027
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)