Establishment of Radiomics Database by Clinical Application of Multiparametric MRI Based on Incoherent Undersampling

December 16, 2021 updated by: Jeong Min Lee, Seoul National University Hospital

Establishment of Radiomics Database by Clinical Application of Multiparametric MRI Including DCE-MRI Based on Incoherent Undersampling

This study aims to establish radiomics database for pancreas cancer from multiparametric MRI including DCE-MRI obtained by using incoherent undersampling and radial acquisition for clinical staging as well as quantitative analysis.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

29

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients who are scheduled to undergo pancreatobiliary MRI as a preoperative workup for suspected resectable pancreas cancer (adenocarcinoma)

Description

Inclusion Criteria:

  • surgical candidate for pancreatico-duodenectomy
  • characteristic finding of pancreatic adenocarcinoma on prior CT or MRI
  • OR histologically diagnosed with pancreatic adenocarcinoma
  • signed for informed consent

Exclusion Criteria:

  • under 18 years
  • not eligible for pancreatico-duodenectomy
  • unresectable patients (locally advanced on prior CT/MRI or metastatic disease)
  • tumors with suspicion of other histologic types (neuroendocrine, IPMN, etc)
  • any contra-indication of contrast-enhanced MRI
  • recurred pancreatic cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
T-staging
Time Frame: 4 weeks after MR acquisition
T-staging of the tumor at MRI.
4 weeks after MR acquisition

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
N-staging
Time Frame: 4 weeks after MR acquisition
N-staging of the tumor at MRI
4 weeks after MR acquisition
arterial blood flow
Time Frame: 4 weeks after MR acquisition
arterial blood flow of the tumor and adjacent parenchma on DCE-MRI
4 weeks after MR acquisition
arterial fraction
Time Frame: 4 weeks after MR acquisition
arterial fraction of the tumor and adjacent parenchyma on DCE-MRI
4 weeks after MR acquisition
mean transit time
Time Frame: 4 weeks after MR acquisition
mean transit time of the tumor and adjacent parenchyma on DCE-MRI
4 weeks after MR acquisition
extracellular volume
Time Frame: 4 weeks after MR acquisition
extracellular volume of the tumor and adjacent parenchyma on DCE-MRI
4 weeks after MR acquisition
true diffusion
Time Frame: 4 weeks after MR acquisition
true diffusion of the tumor and adjacent parenchyma on DWI with intravoxel incoherent motion model
4 weeks after MR acquisition
pseudodiffusion
Time Frame: 4 weeks after MR acquisition
pseudodiffusion of the tumor and adjacent parenchyma on DWI with intravoxel incoherent motion model
4 weeks after MR acquisition
perfusion fraction
Time Frame: 4 weeks after MR acquisition
perfusion fraction of the tumor and adjacent parenchyma on DWI with intravoxel incoherent motion model
4 weeks after MR acquisition
kurtosis
Time Frame: 4 weeks after MR acquisition
kurtosis of the tumor and adjacent parenchyma on DWI with kurtosis model
4 weeks after MR acquisition
mean diffusivity
Time Frame: 4 weeks after MR acquisition
mean diffusivity of the tumor and adjacent parenchyma on DWI with kurtosis model
4 weeks after MR acquisition

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
T1 value
Time Frame: 4 weeks after MR acquisition
T1 value of the tumor and adjacent parenchyma using T1 map
4 weeks after MR acquisition
T2 value
Time Frame: 4 weeks after MR acquisition
T1 value of the tumor and adjacent parenchyma using T2 map
4 weeks after MR acquisition
fat fraction
Time Frame: 4 weeks after MR acquisition
fat fraction of the tumor and adjacent parenchyma using T2* corrected fat map
4 weeks after MR acquisition
global textural feature
Time Frame: 4 weeks after MR acquisition
first order parameters related to the grey level frequency distribution in the region of interest using dedicated software
4 weeks after MR acquisition
local textural feature
Time Frame: 4 weeks after MR acquisition
second order parameters calculated with spatial grey level dependence matrices or co-occurrence matrices using dedicated software
4 weeks after MR acquisition
attenuation
Time Frame: 4 weeks after MR acquisition
hounsefield unit (HU) of the tumor and parameter on CT within 4 weeks of MRI
4 weeks after MR acquisition
transient dyspnea
Time Frame: 1 day after MR acquisition
development of transient dyspnea or involuntary motion after contrast media administration
1 day after MR acquisition

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2016

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

November 1, 2023

Study Registration Dates

First Submitted

October 24, 2016

First Submitted That Met QC Criteria

October 24, 2016

First Posted (Estimate)

October 25, 2016

Study Record Updates

Last Update Posted (Actual)

December 17, 2021

Last Update Submitted That Met QC Criteria

December 16, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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