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.

Study Overview

• Status: Recruiting
• Conditions: PDAC - Pancreatic Ductal Adenocarcinoma
• Intervention / Treatment: Diagnostic test: CT Perfusion

• Study Type: Interventional
• Enrollment (Anticipated): 125
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tom Perik, Msc.; Phone Number: 024 3617899; Email: tom.perik@radboudumc.nl

Study Locations

• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6525GA
      • Recruiting
      • Radboud University Medical Hospital
      • Contact: John Hermans; Email: john.hermans@radboudumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Diagnostic test: CT Perfusion; CT Perfusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Prediction of chemotherapy response	Sensitivity and specificity of CT-perfusion parameters to predict chemotherapy response in patients with pancreatic ductal adenocarcinoma.	Baseline, 3 Months
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

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Collaborators: Dutch Cancer Society
• Investigators: Principal Investigator: John Hermans, MSc, MD, PhD, Radboud University Medical Center; Principal Investigator: Henkjan Huisman, MSc, PhD, Radboud University Medical Center; Principal Investigator: Lodewijk Brosens, Radboud University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2017
• Primary Completion (Actual): December 31, 2022
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: December 20, 2022
• First Submitted That Met QC Criteria: December 20, 2022
• First Posted (Actual): December 30, 2022

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: May 1, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Pancreas; Pancreatic cancer; Imaging Biomarker; Histopathology; CT perfusion
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma
• Other Study ID Numbers: PERFUSION-PANC; 12034 (Other Grant/Funding Number: Dutch Cancer Society)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No