PRetreatment MRI for OCcult Liver Metastasis Assessment In Pancreatic Ductal adenocarcinoMa

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAzienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

No treatment groups listed

Trial outcomes

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.

Time frame
Through study completion, an average of 18 months

Secondary outcomes

1

Identification of the target sequences

Identification of the most accurate sequences for detecting MEOs on MRI

Time frame
Through study completion, an average of 18 months

Other outcomes

1

Predictive model creation

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

Time frame
Through study completion, an average of 18 months

Sponsors and contacts

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