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NCT Number: NCT07252076

PRetreatment MRI for OCcult Liver Metastasis Assessment In Pancreatic Ductal adenocarcinoMa

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

SC Chirurgia Generale

Alessandria, Piedmont, 15121, Italy

Location status: Recruiting

Location contact

SC Chirurgia Generale

CONTACT

[email protected]

0131206893

About this study

Pancreatic cancer (PC) is a deadly disease with a low five-year survival rate, mainly due to late diagnosis and distant metastases, particularly to the liver. Computed tomography (CT) is the conventional diagnostic method, but it does not always detect hidden liver metastases, which are often only identified during surgery. Recent studies suggest that the use of magnetic resonance imaging (MRI), especially with diffusion-weighted imaging (DWI) sequences, could improve the detection of occult liver metastases, even those smaller than one centimeter, and thus influence treatment decisions, reducing unnecessary surgery.

However, the adoption of MRI as standard practice is not yet widespread, due to the lack of evidence and its limited use in specific situations. This study proposes integrating contrast-enhanced MRI and DWI into the diagnostic protocol to refine diagnostic accuracy and therapeutic choices, with the aim of optimizing treatment and survival in patients with pancreatic cancer.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. Percentage of patients

    Time frame: Through study completion, an average of 18 months

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

Secondary outcomes

  1. Identification of the target sequences

    Time frame: Through study completion, an average of 18 months

    Identification of the most accurate sequences for detecting MEOs on MRI

Other outcomes

  1. Predictive model creation

    Time frame: Through study completion, an average of 18 months

    Based on the results of the first objective, a predictive model will be created, to identify patients at high risk of MEO.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trial Center Clinical Trial Center

CONTACT

[email protected]

0131206893

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

Other

Registry information

Official study title

PRetreatment MRI for OCcult Liver Metastasis Assessment In Pancreatic Ductal adenocarcinoMa. An International Multicentric, Prospective, Diagnostic Accuracy Trial

Acronym: PROCLAIM

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Nov 26, 2025
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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