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

Pancreas Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02944006
• Other study ID #: 2015-1160
• Status: Active, not recruiting
• Start date: November 28, 2016
• Est. completion date: November 2023

Study information

• Verified date: December 2021
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 29
• Est. completion date: November 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreas Cancer
• Pancreatic Neoplasms

Intervention

Procedure:
• multi-parametric MRI
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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	T1 value	T1 value of the tumor and adjacent parenchyma using T1 map	4 weeks after MR acquisition
Other	T2 value	T1 value of the tumor and adjacent parenchyma using T2 map	4 weeks after MR acquisition
Other	fat fraction	fat fraction of the tumor and adjacent parenchyma using T2* corrected fat map	4 weeks after MR acquisition
Other	global textural feature	first order parameters related to the grey level frequency distribution in the region of interest using dedicated software	4 weeks after MR acquisition
Other	local textural feature	second order parameters calculated with spatial grey level dependence matrices or co-occurrence matrices using dedicated software	4 weeks after MR acquisition
Other	attenuation	hounsefield unit (HU) of the tumor and parameter on CT within 4 weeks of MRI	4 weeks after MR acquisition
Other	transient dyspnea	development of transient dyspnea or involuntary motion after contrast media administration	1 day after MR acquisition
Primary	T-staging	T-staging of the tumor at MRI.	4 weeks after MR acquisition
Secondary	N-staging	N-staging of the tumor at MRI	4 weeks after MR acquisition
Secondary	arterial blood flow	arterial blood flow of the tumor and adjacent parenchma on DCE-MRI	4 weeks after MR acquisition
Secondary	arterial fraction	arterial fraction of the tumor and adjacent parenchyma on DCE-MRI	4 weeks after MR acquisition
Secondary	mean transit time	mean transit time of the tumor and adjacent parenchyma on DCE-MRI	4 weeks after MR acquisition
Secondary	extracellular volume	extracellular volume of the tumor and adjacent parenchyma on DCE-MRI	4 weeks after MR acquisition
Secondary	true diffusion	true diffusion of the tumor and adjacent parenchyma on DWI with intravoxel incoherent motion model	4 weeks after MR acquisition
Secondary	pseudodiffusion	pseudodiffusion of the tumor and adjacent parenchyma on DWI with intravoxel incoherent motion model	4 weeks after MR acquisition
Secondary	perfusion fraction	perfusion fraction of the tumor and adjacent parenchyma on DWI with intravoxel incoherent motion model	4 weeks after MR acquisition
Secondary	kurtosis	kurtosis of the tumor and adjacent parenchyma on DWI with kurtosis model	4 weeks after MR acquisition
Secondary	mean diffusivity	mean diffusivity of the tumor and adjacent parenchyma on DWI with kurtosis model	4 weeks after MR acquisition