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

• Conditions: Pancreas Cancer

• Registration Number: NCT02944006
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-24
• Study First Submitted QC: 2016-10-24
• Study First Posted: 2016-10-25
• Study Start: 2016-11-28
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-16
• Last Update Posted: 2021-12-17
• Primary Completion: 2022-12
• Study Completion: 2023-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 29

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
T-staging	4 weeks after MR acquisition	T-staging of the tumor at MRI.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of