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

Not Applicable

Recruiting

• Conditions: PDAC - Pancreatic Ductal Adenocarcinoma
• Interventions: Diagnostic Test: CT Perfusion

• Registration Number: NCT05669287
• Lead Sponsor: Radboud University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-22
• Status Verified: 2022-12
• Study First Submitted: 2022-12-20
• Study First Submitted QC: 2022-12-20
• Study First Posted: 2022-12-30
• Primary Completion: 2022-12-31
• Last Update Submitted: 2023-05-01
• Last Update Posted: 2023-05-03
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 125

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CT Perfusion	CT Perfusion	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.

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Radboud University Medical Hospital; 🇳🇱 Nijmegen, Gelderland, Netherlands