NCT02201797

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 28, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

June 24, 2015

Status Verified

June 1, 2015

Enrollment Period

8 months

First QC Date

July 24, 2014

Last Update Submit

June 22, 2015

Conditions

Metastatic Liver Cancer

Keywords

Reproducibility of ResultsLiver neoplasmNeoplasm metastasisRegional PerfusionPerfusion Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

  • repeatability coefficient (RC)

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

    one year

Study Arms (1)

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

DCE MRIOTHER
DCE and DWI MRI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

MeSH Terms

Conditions

Liver NeoplasmsNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kyung Won Kim, M.D.

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistance Professor

Study Record Dates

First Submitted

July 24, 2014

First Posted

July 28, 2014

Study Start

October 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

June 24, 2015

Record last verified: 2015-06

Locations

KR(1)