Back to resultsDefining a Vascular Phenotype of Pancreatic Ductal Adenocarcinoma With CT Perfusion Using Quantitative Radiomics
Primary Purpose
PDAC - Pancreatic Ductal Adenocarcinoma
Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
CT Perfusion
Sponsored by
About this trial
This is an interventional diagnostic trial for PDAC - Pancreatic Ductal Adenocarcinoma focused on measuring Pancreas, Pancreatic cancer, CT perfusion, Histopathology, Imaging Biomarker
Eligibility Criteria
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
Sites / Locations
- Radboud University Medical HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CT Perfusion
Arm Description
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.
Outcomes
Primary Outcome Measures
Classification of vascular phenotype using CT-perfusion
To classify a vascular phenotype with CTP using automated perfusion analysis in patients with pancreatic ductal adenocarcinoma
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
Secondary Outcome Measures
Association between survival and CT-perfusion features
Automated AI analysis of survival using CT perfusion in patients with pancreatic ductal adenocarcinoma.
Prediction of chemotherapy response
Sensitivity and specificity of CT-perfusion parameters to predict chemotherapy response in patients with pancreatic ductal adenocarcinoma.
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.
Full Information
NCT ID
NCT05669287
First Posted
December 20, 2022
Last Updated
May 1, 2023
Sponsor
Radboud University Medical Center
Collaborators
Dutch Cancer Society
1. Study Identification
Unique Protocol Identification Number
NCT05669287
Brief Title
Defining a Vascular Phenotype of Pancreatic Ductal Adenocarcinoma With CT Perfusion Using Quantitative Radiomics
Official Title
Defining a Vascular Phenotype of Pancreatic Ductal Adenocarcinoma With CT Perfusion Using Quantitative Radiomics
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 22, 2017 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
June 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
Collaborators
Dutch Cancer Society
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PDAC - Pancreatic Ductal Adenocarcinoma
Keywords
Pancreas, Pancreatic cancer, CT perfusion, Histopathology, Imaging Biomarker
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
125 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CT Perfusion
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
CT Perfusion
Intervention Description
CT Perfusion
Primary Outcome Measure Information:
Title
Classification of vascular phenotype using CT-perfusion
Description
To classify a vascular phenotype with CTP using automated perfusion analysis in patients with pancreatic ductal adenocarcinoma
Time Frame
Baseline
Title
Correlation of CT-perfusion features with histopathological features
Description
To correlate the vascular phenotype with histopathologic features (stroma and microvessel density) in patients with pancreatic ductal adenocarcinoma
Time Frame
Baseline, Time of Resection
Secondary Outcome Measure Information:
Title
Association between survival and CT-perfusion features
Description
Automated AI analysis of survival using CT perfusion in patients with pancreatic ductal adenocarcinoma.
Time Frame
Baseline, at 2 Years
Title
Prediction of chemotherapy response
Description
Sensitivity and specificity of CT-perfusion parameters to predict chemotherapy response in patients with pancreatic ductal adenocarcinoma.
Time Frame
Baseline, 3 Months
Title
Prediction of chemotherapy response compared to RECIST
Description
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.
Time Frame
Baseline, 3 Months, 6 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tom Perik, Msc.
Phone
024 3617899
Email
tom.perik@radboudumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Hermans, MSc, MD, PhD
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Henkjan Huisman, MSc, PhD
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lodewijk Brosens
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radboud University Medical Hospital
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6525GA
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Hermans
Email
john.hermans@radboudumc.nl
12. IPD Sharing Statement
Learn more about this trial
Defining a Vascular Phenotype of Pancreatic Ductal Adenocarcinoma With CT Perfusion Using Quantitative Radiomics
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