SC Chirurgia Generale
Alessandria, Piedmont, 15121, Italy
Location status: Recruiting
NCT Number: NCT07252076
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Alessandria, Piedmont, 15121, Italy
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Through study completion, an average of 18 months
Identification of the most accurate sequences for detecting MEOs on MRI
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.
Contact information is provided by the study sponsor or research team.
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Other
PRetreatment MRI for OCcult Liver Metastasis Assessment In Pancreatic Ductal adenocarcinoMa. An International Multicentric, Prospective, Diagnostic Accuracy Trial
Acronym: PROCLAIM
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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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