PDAC - Pancreatic Ductal Adenocarcinoma Clinical Trial
Official title:
Defining a Vascular Phenotype of Pancreatic Ductal Adenocarcinoma With CT Perfusion Using Quantitative Radiomics
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.
Status | Recruiting |
Enrollment | 125 |
Est. completion date | June 1, 2023 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Radboud University Medical Hospital | Nijmegen | Gelderland |
Lead Sponsor | Collaborator |
---|---|
Radboud University Medical Center | Dutch Cancer Society |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | Prediction of chemotherapy response | Sensitivity and specificity of CT-perfusion parameters to predict chemotherapy response in patients with pancreatic ductal adenocarcinoma. | Baseline, 3 Months | |
Secondary | 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 |
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