Reproducibility and Repeatability of Multifunctional MRI... | NCT02201797

Studies
Reproducibility and Repeatability of Multifunctional MRI Biomarkers of the Body

NCT02201797

Sponsor

Asan Medical Center

Status

Completed

Last Update Posted

Jun 24, 2015Estimated

Enrollment

13Actual

Phase

Not Applicable

Conditions

Metastatic Liver Cancer

Interventions

DCE MRI

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2014

Primary Completion Date

Jun 2015Actual

Completion Date

Jun 2015Actual

First Submitted Date

Jul 24, 2014

First Submission Date that Met QC Criteria

Jul 24, 2014

First Posted Date

Jul 28, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 22, 2015

Last Update Posted Date

Jun 24, 2015Estimated

Name	Class
Bracco Diagnostics, Inc	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

13Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DCE and DWI MRI	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DCE MRI	Other		DCE and DWI MRI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
repeatability coefficient (RC)	Repeatability coefficient of Ktrans, Kep, Ve, IAUGC60, and ADC value of the index tumor will be measured.	one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kyung Won Kim, M.D.	Asan Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asan Medical Center		Seoul		138-736	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D008113	Liver Neoplasms
D009362	Neoplasm Metastasis

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided