Unique ID issued by UMIN | UMIN000043087 |
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Receipt number | R000049173 |
Scientific Title | Proportion of false positive hepatic lesions identified by EOB-MRI |
Date of disclosure of the study information | 2021/01/25 |
Last modified on | 2023/12/05 15:43:42 |
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
Proportion of false positive hepatic lesions identified by EOB-MRI
Japan |
Hepatic tumor scheduled for surgical resection
Hepato-biliary-pancreatic surgery | Radiology |
Malignancy
NO
Frequency of false-positive lesions misdiagnosed as malignant tumor by MRI using Gadoxetate Sodium (Primovist; Bayer Schering Pharma, Osaka, Japan).
Efficacy
Confirmatory
Proportion of hepatic lesions finally revealed as non-malignant among the lesions with the diagnosis of malignant tumor by EOB-MRI.
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.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Diagnosis
Other |
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 basically considered as observational study. When there is any tumor that is recognized as malignant tumor but cannot be identified intraoperatively and is not surgically resected, EOB-MRI is performed for the purpose of final qualitative diagnosis of the unresected lesion. Therefore, the study is defined as observational study with intervention.
20 | years-old | <= |
Not applicable |
Male and Female
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.
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.
100
1st name | Yoji |
Middle name | |
Last name | Kishi |
National Defense Medical College
Hepatobiliary and Pancreatic Surgery Division
359-8513
3-2 Namiki, Tokorozawa-city, Saitama, Japan
+81429951211
ykishi-3su@ndmc.ac.jp
1st name | Yoji |
Middle name | |
Last name | Kishi |
National Defense Medical College
Hepatobiliary and Pancreatic Surgery Division
359-8513
3-2 Namiki, Tokorozawa-city, Saitama, Japan
+81429951211
ykishi-3su@ndmc.ac.jp
National Defense Medical College
Foundation for Promotion of Defense Medicine
Non profit foundation
National Defense Medical College
3-2 Namiki, Tokorozawa-city, Saitama, Japan
2356
ins010@ndmc.ac.jp
NO
2021 | Year | 01 | Month | 25 | Day |
Unpublished
No longer recruiting
2020 | Year | 06 | Month | 02 | Day |
2020 | Year | 07 | Month | 28 | Day |
2020 | Year | 08 | Month | 01 | Day |
2024 | Year | 07 | Month | 31 | Day |
2021 | Year | 01 | Month | 22 | Day |
2023 | Year | 12 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049173
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