Reproducibility and Repeatability of Multifunctional MRI Biomarkers of the Body

Metastatic Liver Cancer Clinical Trial

Official title:

Reproducibility and Repeatability of Multifunctional MRI Biomarkers of the Body

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02201797
• Other study ID #: 2014-0060
• Status: Completed
• Phase: N/A
• First received: July 24, 2014
• Last updated: June 22, 2015
• Start date: October 2014
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Liver Neoplasms
• Metastatic Liver Cancer

Intervention

Other:
• DCE MRI

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Asan Medical Center	Bracco Diagnostics, Inc

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	repeatability coefficient (RC)	Repeatability coefficient of Ktrans, Kep, Ve, IAUGC60, and ADC value of the index tumor will be measured.	one year	No