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Reproducibility and Repeatability of Multifunctional MRI Biomarkers of the Body

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02201797
Recruitment Status : Completed
First Posted : July 28, 2014
Last Update Posted : June 24, 2015
Bracco Diagnostics, Inc
Information provided by (Responsible Party):
Kyung Won Kim, Asan Medical Center

Brief Summary:
Advanced MRI (Magnetic Resonance Imaging) technique called DCE (Dynamic Contrast Enhanced) and DWI MRI can provide valuable information regarding tumor biology and response to treatment through various parameters. Validating stability of these parameters will further establish robustness and reliability of these promising biomarkers.

Condition or disease Intervention/treatment Phase
Metastatic Liver Cancer Other: DCE MRI Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Reproducibility and Repeatability of Multifunctional MRI Biomarkers of the Body
Study Start Date : October 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Arm Intervention/treatment
Experimental: DCE and DWI MRI
MRI SCAN 1 and MRI SCAN 2 must be completed no less than 2 calendar days (to ensure 24 hours for clearance of gadolinium) and no greater than 14 days apart, and both must be completed prior to new treatment initiation. The same MRI unit and configuration must be used for MRI SCAN 1 and MRI SCAN 2.
Other: DCE MRI

Primary Outcome Measures :
  1. repeatability coefficient (RC) [ Time Frame: one year ]
    Repeatability coefficient of Ktrans, Kep, Ve, IAUGC60, and ADC value of the index tumor will be measured.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of metastatic liver cancer proven by pathology
  • At least one liver tumor should be > 2cm in long diameter
  • Patients with viable tumor proven in the other imaging modalities

Exclusion Criteria:

  • Severe claustrophobia
  • Presence of MRI‐incompatible metallic objects or implanted medical devices in body
  • Renal failure, as determined by glomerular filtration rate (GFR) < 30 mL/min/1.73 m2
  • Weight greater than that allowable by the MRI table
  • Chemotherapy within 28 days prior to enrollment
  • Prior external radiation therapy to the liver, prior transarterial chemoembolization

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 identifier (NCT number): NCT02201797

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Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Bracco Diagnostics, Inc
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Principal Investigator: Kyung Won Kim, M.D. Asan Medical Center

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Responsible Party: Kyung Won Kim, Assistance Professor, Asan Medical Center Identifier: NCT02201797     History of Changes
Other Study ID Numbers: 2014-0060
First Posted: July 28, 2014    Key Record Dates
Last Update Posted: June 24, 2015
Last Verified: June 2015

Keywords provided by Kyung Won Kim, Asan Medical Center:
Reproducibility of Results
Liver neoplasm
Neoplasm metastasis
Regional Perfusion
Perfusion Magnetic Resonance Imaging

Additional relevant MeSH terms:
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Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases