Defining a Vascular Phenotype of Pancreatic Ductal Adenocarcinoma With CT Perfusion Using Quantitative Radiomics

Study Overview
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Brief Summary
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With CT-perfusion(CTP) it is possible to visualize the enhancement pattern of the tumor. The perfusion CT, interleaved with a routine contrast enhanced CT (CECT) will be performed at diagnosis in all patients (goal: n=125 patients) and at the first follow-up at 3 months in patients treated with systemic therapy (goal: n=50 patients). Also, the histopathology will be collected for resected tumors to perform histopathology analysis. CTP parameters will be correlated to immunohistological findings and clinical outcome. The main goal of the study is to create an AI-assisted method to classify patients with a vascular phenotype of pancreatic ductal adenocarcinoma (PDAC). The investigators expect that this phenotype can be used to predict overall survival and chemotherapy response.

Official Title
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Defining a Vascular Phenotype of Pancreatic Ductal Adenocarcinoma With CT Perfusion Using Quantitative Radiomics

Conditions
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PDAC - Pancreatic Ductal Adenocarcinoma

Intervention / Treatment
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* Diagnostic Test: CT Perfusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical suspicion of pancreatic cancer 18 years and older written (signed and dated) informed consent Exclusion Criteria: Contra-indications to undergo CT (due to untreatable contrast allergy or renal function impairment) Previous treatment for pancreatic cancer Concomitant malignancies. Subjects with prior malignancies must be disease-free for at least 5 years Insufficient command of the Dutch language to be able to understand the patient information

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CT Perfusion<br>All patients will receive a baseline CT Perfusion scan. A subgroup of patients with chemotherapy treatment will receive a follow-up CT Perfusion after 3 months. | Diagnostic Test: CT Perfusion<br>* CT Perfusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Classification of vascular phenotype using CT-perfusion | To classify a vascular phenotype with CTP using automated perfusion analysis in patients with pancreatic ductal adenocarcinoma | Baseline | 
| Correlation of CT-perfusion features with histopathological features | To correlate the vascular phenotype with histopathologic features (stroma and microvessel density) in patients with pancreatic ductal adenocarcinoma | Baseline, Time of Resection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between survival and CT-perfusion features | Automated AI analysis of survival using CT perfusion in patients with pancreatic ductal adenocarcinoma. | Baseline, at 2 Years | 
| Prediction of chemotherapy response | Sensitivity and specificity of CT-perfusion parameters to predict chemotherapy response in patients with pancreatic ductal adenocarcinoma. | Baseline, 3 Months | 
| Prediction of chemotherapy response compared to RECIST | Sensitivity and specificity of CT-perfusion parameters to evaluate chemotherapy response in patients with pancreatic ductal adenocarcinoma, compared to RECIST 1.1 on conventional CECT. | Baseline, 3 Months, 6 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreas, Pancreatic cancer, CT perfusion, Histopathology, Imaging Biomarker