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Clinical Trials/NCT05669287
NCT05669287RecruitingNot Applicable

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

Radboud University Medical Center2 sites in 1 country125 target enrollmentStarted: December 22, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
125
Locations
2
Primary Endpoint
Correlation of CT-perfusion features with histopathological features

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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-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

Outcomes

Primary Outcomes

Correlation of CT-perfusion features with histopathological features

Time Frame: 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

Time Frame: Baseline

To classify a vascular phenotype with CTP using automated perfusion analysis in patients with pancreatic ductal adenocarcinoma

Secondary Outcomes

  • Association between survival and CT-perfusion features(Baseline, at 2 Years)
  • Prediction of chemotherapy response(Baseline, 3 Months)
  • Prediction of chemotherapy response compared to RECIST(Baseline, 3 Months, 6 Months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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