Establishment of Radiomics Database by Clinical Application of Multiparametric MRI Based on Incoherent Undersampling
1 other identifier
observational
29
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 24, 2016
CompletedFirst Posted
Study publicly available on registry
October 25, 2016
CompletedStudy Start
First participant enrolled
November 28, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2023
CompletedDecember 17, 2021
December 1, 2021
6 years
October 24, 2016
December 16, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
T-staging
T-staging of the tumor at MRI.
4 weeks after MR acquisition
Secondary Outcomes (10)
N-staging
4 weeks after MR acquisition
arterial blood flow
4 weeks after MR acquisition
arterial fraction
4 weeks after MR acquisition
mean transit time
4 weeks after MR acquisition
extracellular volume
4 weeks after MR acquisition
- +5 more secondary outcomes
Other Outcomes (7)
T1 value
4 weeks after MR acquisition
T2 value
4 weeks after MR acquisition
fat fraction
4 weeks after MR acquisition
- +4 more other outcomes
Interventions
multiparametric MRI is performed in all patients, and the sequence includes dynamic contrast enhanced (DCE) MRI, diffusion weighted imaging (DWI), tissue maps, and MR cholangiography.
Eligibility Criteria
Patients who are scheduled to undergo pancreatobiliary MRI as a preoperative workup for suspected resectable pancreas cancer (adenocarcinoma)
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeong Min Lee, MD
Seoul National University Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 24, 2016
First Posted
October 25, 2016
Study Start
November 28, 2016
Primary Completion
December 1, 2022
Study Completion
November 1, 2023
Last Updated
December 17, 2021
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will not share