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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05669287
Other study ID # PERFUSION-PANC
Secondary ID 12034
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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