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

• Sponsor: Radboud University Medical Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05669287
• Collaborator: Dutch Cancer Society (Other)
• Enrollment: 125
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 65.3
• Patients Per Site Per Month: 1.9

Study Details

Study Description

Brief Summary

With CT perfusion it is possible to visualize the enhancement pattern of the tumor. The perfusion CT, added during the routine CECT scan 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, we will collect histopathology of the resected tumors to perform histopathology analysis. We will correlate the CTP parameters 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 PDAC. We expect that we can use this phenotype to predict overall survival and chemotherapy response.

Condition or Disease	Intervention/Treatment	Phase
PDAC - Pancreatic Ductal Adenocarcinoma	Diagnostic Test: CT Perfusion	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 125 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Defining a Vascular Phenotype of Pancreatic Ductal Adenocarcinoma With CT Perfusion Using Quantitative Radiomics
• Actual Study Start Date: Dec 22, 2017
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Jun 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Vascular phenotype [Baseline]

   To classify a vascular phenotype with CTP using AI-assisted analysis

2. Histopathologic features [Baseline, Time of Resection]

   To correlate the vascular phenotype with histopathologic features (stroma and microvessel density)

Secondary Outcome Measures

1. Clinical outcome [Baseline, at 2 Years]

   Automated AI analysis of survival using CT perfusion in pancreatic cancer

2. Prediction of chemotherapy response [Baseline, 3 Months]

   Sensitivity and specificity of CTP parameters to predict chemotherapy response in patients with pancreatic ductal adenocarcinoma.

3. Prediction of chemotherapy response compared to RECIST [Baseline, 3 Months, 6 Months]

   Sensitivity and specificity of CTP parameters to evaluate chemotherapy response in patients with pancreatic ductal adenocarcinoma, compared to RECIST 1.1 on conventional CECT.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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-indictations 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Radboud University Medical Hospital	Nijmegen	Gelderland	Netherlands	6525GA

Sponsors and Collaborators

• Radboud University Medical Center
• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Radboud University Medical Center
• ClinicalTrials.gov Identifier: NCT05669287
• Other Study ID Numbers: PERFUSION-PANC; 12034
• First Posted: Dec 30, 2022
• Last Update Posted: Dec 30, 2022
• Last Verified: Dec 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Radboud University Medical Center: Pancreas; Pancreatic cancer; CT perfusion; Histopathology; Imaging Biomarker
• Additional relevant MeSH terms: Adenocarcinoma

Study Results

No Results Posted as of Dec 30, 2022