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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seoul National University Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 28, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 24, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 25, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 17, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2015-1160

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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