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

Radboud University Medical Center125 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

125

Conditions

PDAC - Pancreatic Ductal Adenocarcinoma

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Classification of vascular phenotype using CT-perfusion

To classify a vascular phenotype with CTP using automated perfusion analysis in patients with pancreatic ductal adenocarcinoma

Time frame: 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

Time frame: Baseline, Time of Resection

Secondary Outcomes

Association between survival and CT-perfusion features

Automated AI analysis of survival using CT perfusion in patients with pancreatic ductal adenocarcinoma.

Time frame: 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.

Time frame: 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.

Time frame: Baseline, 3 Months, 6 Months