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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05669287

Enrollment

125

Registered

2022-12-30

Start date

2017-12-22

Completion date

2023-06-01

Last updated

2023-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PDAC - Pancreatic Ductal Adenocarcinoma

Keywords

Pancreas, Pancreatic cancer, CT perfusion, Histopathology, Imaging Biomarker

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.

Interventions

DIAGNOSTIC_TESTCT Perfusion

CT Perfusion

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Netherlands

Contacts

Primary ContactTom Perik, Msc.

tom.perik@radboudumc.nl024 3617899

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026