- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02944006
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
-
-
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Seoul, Korea, Republic of
- Seoul National University Hospital
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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
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global textural feature
Time Frame: 4 weeks after MR acquisition
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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
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transient dyspnea
Time Frame: 1 day after MR acquisition
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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
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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