PRetreatment MRI for OCcult Liver Metastasis Assessment In Pancreatic Ductal adenocarcinoMa
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Contrast-enhanced MRI and DWI sequences.
- Who it may be relevant to
- Registry conditions: Pancreatic Ductal Adenocarcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
PRetreatment MRI for OCcult Liver Metastasis Assessment In Pancreatic Ductal adenocarcinoMa. An International Multicentric, Prospective, Diagnostic Accuracy Trial
Overview
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.
Detailed description
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.
Interventions
- Radiation Contrast-enhanced MRI and DWI sequences
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 outcome measures
- Percentage of patients [Time frame: Through study completion, an average of 18 months]
Secondary outcome measures (1)
- Identification of the target sequences [Time frame: Through study completion, an average of 18 months]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- SC Chirurgia Generale — Alessandria
Identifiers
NCT: NCT07252076 · ASO.ChirGen.25.03