Reproducibility and Repeatability of Multifunctional MRI Biomarkers of the Body

Asan Medical Center

Status: Completed

Conditions: Metastatic Liver Cancer

Treatments: Other: DCE MRI

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02201797

2014-0060

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

DCE and DWI MRI

Experimental group

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.

Treatment:

Other: DCE MRI