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

NCT ID: NCT05669287

Last Updated: 2023-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-22

Study Completion Date

2023-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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PDAC - Pancreatic Ductal Adenocarcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

CT Perfusion

Intervention Type DIAGNOSTIC_TEST

CT Perfusion

Interventions

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CT Perfusion

CT Perfusion

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dutch Cancer Society

OTHER

Sponsor Role collaborator

Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Hermans, MSc, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Henkjan Huisman, MSc, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Lodewijk Brosens

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

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Radboud University Medical Hospital

Nijmegen, Gelderland, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Tom Perik, Msc.

Role: CONTACT

024 3617899

Facility Contacts

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John Hermans

Role: primary

Other Identifiers

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12034

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PERFUSION-PANC

Identifier Type: -

Identifier Source: org_study_id

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