Pancreatic Ductal Adenocarcinoma
Conditions
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.
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
RADIATIONContrast-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.
Sponsors
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients | 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
| Measure | Time frame | Description |
|---|---|---|
| Identification of the target sequences | Through study completion, an average of 18 months | Identification of the most accurate sequences for detecting MEOs on MRI |
Other
| Measure | Time frame | Description |
|---|---|---|
| Predictive model creation | 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. |
Countries
Italy
Contacts
Primary ContactClinical Trial Center Clinical Trial Center
Outcome results
None listed