Defining a Vascular Phenotype of Pancreatic Ductal Adenocarcinoma With CT Perfusion Using Quantitative Radiomics
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 125
- Locations
- 2
- Primary Endpoint
- Correlation of CT-perfusion features with histopathological features
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Correlation of CT-perfusion features with histopathological features
Time Frame: Baseline, Time of Resection
To correlate the vascular phenotype with histopathologic features (stroma and microvessel density) in patients with pancreatic ductal adenocarcinoma
Classification of vascular phenotype using CT-perfusion
Time Frame: Baseline
To classify a vascular phenotype with CTP using automated perfusion analysis in patients with pancreatic ductal adenocarcinoma
Secondary Outcomes
- Association between survival and CT-perfusion features(Baseline, at 2 Years)
- Prediction of chemotherapy response(Baseline, 3 Months)
- Prediction of chemotherapy response compared to RECIST(Baseline, 3 Months, 6 Months)