Proportion of false positive hepatic lesions identified by EOB-MRI

Proportion of false positive hepatic lesions identified by EOB-MRI - Proportion of false positive hepatic lesions identified by EOB-MRI

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000043087

Enrollment

100

Registered

2021-01-25

Start date

2020-08-01

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

Hepatic tumor scheduled for surgical resection

Interventions

Because both CE-CT and EOB-MRI for the diagnosis of hepatic tumors are covered by national insurance and have been routinely performed in the patients scheduled for hepatectomy, this study is basicall

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients scheduled for hepatectomy for any kinds of hepatic tumors. Patients who have already undergone CE-CT or EOB-MRI can also be enrolled. 2) Age of 20 years or older as the time or registration. 3) History of previous chemotherapy is not concerned. 4) Patients with ECOG performance status of 0 or 1. 5) Patients with eGFR of 40 ml/min or higher. 6) Patients with informed consent.

Exclusion criteria

Exclusion criteria: 1) Patients without CE-CT or EOB-MRI within 8 weeks before the day of hepatectomy. 2) Patients prohibited to undergo CE-CT or EOB-MRI due to the following reasons. a. History of allergy to contrast enhancement materials. b. History of bronchial asthma. c. Patient with any kinds of metallic equipment that are not allowed for MRI. d. History of claustrophobia. 3) Patients considered by primary physician to be inappropriate to attend the study due to psychologic issues. 4) Patients with pregnancy or suspected to be pregnant. 5) Patients considered by primary physician to be inappropriate to attend the study due to any other reasons.

Design outcomes

Primary

Measure	Time frame
Proportion of hepatic lesions finally revealed as non-malignant among the lesions with the diagnosis of malignant tumor by EOB-MRI.	—

Secondary

Measure	Time frame
1. Proportion of hepatic lesions finally revealed as non-malignant among the lesions with the diagnosis of malignant tumor by contrast enhanced CT (CE-CT). 2. Distribution of sites and size of false positive lesions by EOB-MRI or CE-CT. 3. Sensitivity and Positive predictive value for the diagnosis of malignant liver tumor by EOB-MRI. 4. The concordance rate among the different radiologists. 5. Frequency of equivocal lesions that are difficult to make qualitative diagnosis.	—

Measure

Time frame

1. Proportion of hepatic lesions finally revealed as non-malignant among the lesions with the diagnosis of malignant tumor by contrast enhanced CT (CE-CT). 2. Distribution of sites and size of false positive lesions by EOB-MRI or CE-CT. 3. Sensitivity and Positive predictive value for the diagnosis of malignant liver tumor by EOB-MRI. 4. The concordance rate among the different radiologists. 5. Frequency of equivocal lesions that are difficult to make qualitative diagnosis.

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Countries

Japan

Contacts

Public ContactYoji Kishi

National Defense Medical College Hepatobiliary and Pancreatic Surgery Division

ykishi-3su@ndmc.ac.jp+81429951211

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026