Study of clinical data correlation between liver enhancement and liver function, and time point on hepatocyte phase of gadoxetic acid enhanced MRI

Study of clinical data correlation between liver enhancement and liver function, and time point on hepatocyte phase of gadoxetic acid enhanced MRI - Gadoxetic Acid Liver-enhanced MRI: Observational Study (GALIREO Study)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000008229

Enrollment

1800

Registered

2012-07-01

Start date

2012-07-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular carcinoma

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patient, who need EOB enhanced MRI (2) Clinical examination data can be obtained within one month before EOB enhanced MRI (3) Less than upper limit of normal serum creatinine level (4) Less than 100 kg of patient body weight (5) Consciousness of patient is clear

Exclusion criteria

Exclusion criteria: (1) Patients with contraindications of MRI (such as pacemaker) (2) Patients with a history of hypersensitivity to gadolinium contrast agent (3)Patients with bronchial asthma or severe allergic disease (4) Patients with severe renal dysfunction (5)Pregnant patients, and patients during lactation

Design outcomes

Primary

Measure	Time frame
Primary endpoints (1) Relationship between "sufficient liver enhancement" at hepatobiliary phase and clinical (including Child-Pugh classification, ICG-R15) Liver-spleen contrast is defined, in accordance with the report by Motosugi et al. as follows: liver-spleen contrast = the signal intensity of the liver / signal intensity of spleen () "Sufficient liver enhancement" is defined, in accordance with the report by Motosugi et al, as follows: liver-spleen contrast calculated in is > or = 1.5. It will statistically be investigated if hepatobiliary images at 20 minutes after the administration of gadoxetic acid are associated with "sufficient liver enhancement" or not and their relationship with each parameter of the clinical laboratory test.	—

Measure

Time frame

Primary endpoints (1) Relationship between "sufficient liver enhancement" at hepatobiliary phase and clinical (including Child-Pugh classification, ICG-R15) Liver-spleen contrast is defined, in accordance with the report by Motosugi et al. as follows: liver-spleen contrast = the signal intensity of the liver / signal intensity of spleen (*) "Sufficient liver enhancement" is defined, in accordance with the report by Motosugi et al, as follows: liver-spleen contrast calculated in * is > or = 1.5. It will statistically be investigated if hepatobiliary images at 20 minutes after the administration of gadoxetic acid are associated with "sufficient liver enhancement" or not and their relationship with each parameter of the clinical laboratory test.

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Secondary

Measure	Time frame
(1) Relationship between liver-spleen contrast at hepatobiliary phase and clinical laboratory parameters (including Child-Pugh classification, ICG-R15) (2) Comparison of liver-spleen contrast between each time point of hepatobiliary phase (3) Comparison of lesion-liver contrasts between time points of hepatobiliary phase imaging (4) Safety endpoints Safety parameters include evaluation of the general tolerance index reported by patients and doctors, adverse events (AEs) and their types and severity.	—

Measure

Time frame

(1) Relationship between liver-spleen contrast at hepatobiliary phase and clinical laboratory parameters (including Child-Pugh classification, ICG-R15) (2) Comparison of liver-spleen contrast between each time point of hepatobiliary phase (3) Comparison of lesion-liver contrasts between time points of hepatobiliary phase imaging (4) Safety endpoints Safety parameters include evaluation of the general tolerance index reported by patients and doctors, adverse events (AEs) and their types and severity.

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Countries

Japan

Contacts

Public ContactMasahiro Okada

Kinki University Faculty of Medicine Department of Radiology

mokada@radiol.med.kindai.ac.jp072-366-0221

Outcome results