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

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ClinicalTrials.gov Identifier: NCT02944006
Recruitment Status : Recruiting
First Posted : October 25, 2016
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
Jeong Min Lee, 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.

Condition or disease Intervention/treatment
Pancreas Cancer Procedure: multi-parametric MRI

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Study Type : Observational
Estimated Enrollment : 25 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
Study Start Date : December 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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.


Primary Outcome Measures :
  1. T-staging [ Time Frame: 4 weeks after MR acquisition ]
    T-staging of the tumor at MRI.


Secondary Outcome Measures :
  1. N-staging [ Time Frame: 4 weeks after MR acquisition ]
    N-staging of the tumor at MRI

  2. arterial blood flow [ Time Frame: 4 weeks after MR acquisition ]
    arterial blood flow of the tumor and adjacent parenchma on DCE-MRI

  3. arterial fraction [ Time Frame: 4 weeks after MR acquisition ]
    arterial fraction of the tumor and adjacent parenchyma on DCE-MRI

  4. mean transit time [ Time Frame: 4 weeks after MR acquisition ]
    mean transit time of the tumor and adjacent parenchyma on DCE-MRI

  5. extracellular volume [ Time Frame: 4 weeks after MR acquisition ]
    extracellular volume of the tumor and adjacent parenchyma on DCE-MRI

  6. true diffusion [ Time Frame: 4 weeks after MR acquisition ]
    true diffusion of the tumor and adjacent parenchyma on DWI with intravoxel incoherent motion model

  7. pseudodiffusion [ Time Frame: 4 weeks after MR acquisition ]
    pseudodiffusion of the tumor and adjacent parenchyma on DWI with intravoxel incoherent motion model

  8. perfusion fraction [ Time Frame: 4 weeks after MR acquisition ]
    perfusion fraction of the tumor and adjacent parenchyma on DWI with intravoxel incoherent motion model

  9. kurtosis [ Time Frame: 4 weeks after MR acquisition ]
    kurtosis of the tumor and adjacent parenchyma on DWI with kurtosis model

  10. mean diffusivity [ Time Frame: 4 weeks after MR acquisition ]
    mean diffusivity of the tumor and adjacent parenchyma on DWI with kurtosis model


Other Outcome Measures:
  1. T1 value [ Time Frame: 4 weeks after MR acquisition ]
    T1 value of the tumor and adjacent parenchyma using T1 map

  2. T2 value [ Time Frame: 4 weeks after MR acquisition ]
    T1 value of the tumor and adjacent parenchyma using T2 map

  3. fat fraction [ Time Frame: 4 weeks after MR acquisition ]
    fat fraction of the tumor and adjacent parenchyma using T2* corrected fat map

  4. global textural feature [ Time Frame: 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 [ Time Frame: 4 weeks after MR acquisition ]
    second order parameters calculated with spatial grey level dependence matrices or co-occurrence matrices using dedicated software

  6. attenuation [ Time Frame: 4 weeks after MR acquisition ]
    hounsefield unit (HU) of the tumor and parameter on CT within 4 weeks of MRI

  7. transient dyspnea [ Time Frame: 1 day after MR acquisition ]
    development of transient dyspnea or involuntary motion after contrast media administration



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who are scheduled to undergo pancreatobiliary MRI as a preoperative workup for suspected resectable pancreas cancer (adenocarcinoma)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02944006


Contacts
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Contact: Hyun Hee Lee, RN 82-2-2072-4177 redlion55@naver.com
Contact: Jeong Hee Yoon, MD 82-2-2072-2293 jhjhry@gmail.com

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Hyun Hee Lee, RN    82-2-2072-4177    redlion55@naver.com   
Contact: Jeong Hee Yoon, MD    82-2-2072-2293    jhjhry@gmail.com   
Principal Investigator: Jeong Min Lee, MD, PhD         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Jeong Min Lee, MD Seoul National University Hospital

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Responsible Party: Jeong Min Lee, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02944006     History of Changes
Other Study ID Numbers: 2015-1160
First Posted: October 25, 2016    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jeong Min Lee, Seoul National University Hospital:
MRI
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases