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

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02944006
• Collaborator: (none)
• Enrollment: 29
• Location: 1
• Anticipated Duration (Months): 83.1
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreas Cancer	Procedure: multi-parametric MRI

Study Design

• Study Type: Observational
• Actual Enrollment: 29 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Establishment of Radiomics Database by Clinical Application of Multiparametric MRI Including DCE-MRI Based on Incoherent Undersampling
• Actual Study Start Date: Nov 28, 2016
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Nov 1, 2023

Outcome Measures

Primary Outcome Measures

1. T-staging [4 weeks after MR acquisition]

   T-staging of the tumor at MRI.

Secondary Outcome Measures

1. N-staging [4 weeks after MR acquisition]

   N-staging of the tumor at MRI

2. arterial blood flow [4 weeks after MR acquisition]

   arterial blood flow of the tumor and adjacent parenchma on DCE-MRI

3. arterial fraction [4 weeks after MR acquisition]

   arterial fraction of the tumor and adjacent parenchyma on DCE-MRI

4. mean transit time [4 weeks after MR acquisition]

   mean transit time of the tumor and adjacent parenchyma on DCE-MRI

5. extracellular volume [4 weeks after MR acquisition]

   extracellular volume of the tumor and adjacent parenchyma on DCE-MRI

6. true diffusion [4 weeks after MR acquisition]

   true diffusion of the tumor and adjacent parenchyma on DWI with intravoxel incoherent motion model

7. pseudodiffusion [4 weeks after MR acquisition]

   pseudodiffusion of the tumor and adjacent parenchyma on DWI with intravoxel incoherent motion model

8. perfusion fraction [4 weeks after MR acquisition]

   perfusion fraction of the tumor and adjacent parenchyma on DWI with intravoxel incoherent motion model

9. kurtosis [4 weeks after MR acquisition]

   kurtosis of the tumor and adjacent parenchyma on DWI with kurtosis model

10. mean diffusivity [4 weeks after MR acquisition]

    mean diffusivity of the tumor and adjacent parenchyma on DWI with kurtosis model

Other Outcome Measures

1. T1 value [4 weeks after MR acquisition]

   T1 value of the tumor and adjacent parenchyma using T1 map

2. T2 value [4 weeks after MR acquisition]

   T1 value of the tumor and adjacent parenchyma using T2 map

3. fat fraction [4 weeks after MR acquisition]

   fat fraction of the tumor and adjacent parenchyma using T2* corrected fat map

4. global textural feature [4 weeks after MR acquisition]

   first order parameters related to the grey level frequency distribution in the region of interest using dedicated software

5. local textural feature [4 weeks after MR acquisition]

   second order parameters calculated with spatial grey level dependence matrices or co-occurrence matrices using dedicated software

6. attenuation [4 weeks after MR acquisition]

   hounsefield unit (HU) of the tumor and parameter on CT within 4 weeks of MRI

7. transient dyspnea [1 day after MR acquisition]

   development of transient dyspnea or involuntary motion after contrast media administration

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Seoul National University Hospital

Investigators

• Principal Investigator: Jeong Min Lee, MD, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jeong Min Lee, Professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT02944006
• Other Study ID Numbers: 2015-1160
• First Posted: Oct 25, 2016
• Last Update Posted: Dec 17, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Jeong Min Lee, Professor, Seoul National University Hospital: MRI
• Additional relevant MeSH terms: Pancreatic Neoplasms

Study Results

No Results Posted as of Dec 17, 2021