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Reproducibility and Repeatability of Multifunctional MRI Biomarkers of the Body

Primary Purpose

Metastatic Liver Cancer

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DCE MRI
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Metastatic Liver Cancer focused on measuring Reproducibility of Results, Liver neoplasm, Neoplasm metastasis, Regional Perfusion, Perfusion Magnetic Resonance Imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Asan Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DCE and DWI MRI

Arm Description

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.

Outcomes

Primary Outcome Measures

repeatability coefficient (RC)
Repeatability coefficient of Ktrans, Kep, Ve, IAUGC60, and ADC value of the index tumor will be measured.

Secondary Outcome Measures

Full Information

First Posted
July 24, 2014
Last Updated
June 22, 2015
Sponsor
Asan Medical Center
Collaborators
Bracco Diagnostics, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT02201797
Brief Title
Reproducibility and Repeatability of Multifunctional MRI Biomarkers of the Body
Official Title
Reproducibility and Repeatability of Multifunctional MRI Biomarkers of the Body
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
Collaborators
Bracco Diagnostics, Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Liver Cancer
Keywords
Reproducibility of Results, Liver neoplasm, Neoplasm metastasis, Regional Perfusion, Perfusion Magnetic Resonance Imaging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DCE and DWI MRI
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
DCE MRI
Primary Outcome Measure Information:
Title
repeatability coefficient (RC)
Description
Repeatability coefficient of Ktrans, Kep, Ve, IAUGC60, and ADC value of the index tumor will be measured.
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyung Won Kim, M.D.
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of

12. IPD Sharing Statement

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Reproducibility and Repeatability of Multifunctional MRI Biomarkers of the Body

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