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

PDAC - Pancreatic Ductal Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05669287
• Other study ID #: PERFUSION-PANC
• Secondary ID: 12034
• Status: Recruiting
• Phase: N/A
• Start date: December 22, 2017
• Est. completion date: June 1, 2023

Study information

• Verified date: December 2022
• Source: Radboud University Medical Center
• Contact: Tom Perik, Msc.
• Phone: 024 3617899
• Email: tom.perik[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Adenocarcinoma
• PDAC - Pancreatic Ductal Adenocarcinoma

Intervention

Diagnostic Test:
• CT Perfusion
CT Perfusion

Locations

Country	Name	City	State
Netherlands	Radboud University Medical Hospital	Nijmegen	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University Medical Center	Dutch Cancer Society

Country where clinical trial is conducted

Netherlands, 

Outcome

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