Diagnosis of Nodules ≤2 cm Based on US and CEUS Compared With Current Clinical Procedure
NCT ID: NCT05360420
Last Updated: 2022-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
6730 participants
INTERVENTIONAL
2022-10-26
2024-12-31
Brief Summary
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It is of great significance to consider the cost-effectiveness of each examination based on the principle of cost minimization. Therefore, we propose immediate CEUS examination for suspicious lesions ≤2 cm screened by US, and determine the diagnostic process of further diagnostic methods based on the CEUS results. The aim of this study is to establish a screening and diagnosis process for HCC ≤2 cm suitable for China considering time effect, economic effect and diagnostic efficiency.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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Immediate CEUS group
CEUS (SonoVue) was performed immediately after routine US screening of suspicious lesions. The lesions were classified according to CEUS examination by the diagnosing physician, including consideration of HCC, suspected HCC, and benign lesions. Further hepatobiliary-specific MRI (Modis/Primexian) was performed for lesions considered HCC or suspicious for HCC, and benign lesions were followed up. The diagnostic findings of hepatobiliary-specific MRI were classified by the diagnosing physician and included consideration of HCC, suspected HCC, and benign lesions. For hepatobiliary-specific MRI lesions considered HCC or suspicious for HCC, pathological examination was performed, and benign lesions were followed up.
Immediate CEUS
Subjects will receive CEUS examination immediately for the suspicious lesion detected by US.
Current clinical procedure group
After the suspicious lesions were screened by routine US, CECT, CEMRI and hepatobiliary-specific MRI (the first enhanced imaging examination) were independently selected by clinicians. According to the first examination results of the contrast-enhanced image, the diagnosis was classified by the diagnosing physician, including considering HCC, suspicious HCC, and benign lesions. Another contrast-enhanced imaging examination (CECT or CEMRI or hepatobiliary-specific MRI or CEUS) was performed again for lesions considered or suspected of HCC (second contrast-enhanced imaging study), and negative lesions were followed up. According to the examination results of the second enhanced imaging, the classification includes considering HCC, suspicious HCC, and benign. Pathological examination was performed for lesions considered HCC or suspicious for HCC on the second enhanced image, and benign lesions were followed up.
No interventions assigned to this group
Interventions
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Immediate CEUS
Subjects will receive CEUS examination immediately for the suspicious lesion detected by US.
Eligibility Criteria
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Inclusion Criteria
2. The ages of patients are between 18 and 80.
3. Patients are with solid liver lesion(s) ≤ 2 cm detected by US.
4. Patient signs the informed consent.
Exclusion Criteria
2. Patient's age is \< 18 years old or \> 80 years old.
3. Patients with known hypersensitivity to CEUS, CECT, CEMRI, or hepatobiliary-specific MRI contrast agents.
4. Patient is a pregnant or breastfeeding woman.
5. Patient is not diagnosed based on the reference diagnostic criteria required by the study.
6. Patient is considered to be unsuitable to participate in the study.
18 Years
80 Years
ALL
No
Sponsors
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Tianjin Second People's Hospital
OTHER
Tianjin Medical University Cancer Institute and Hospital
OTHER
Peking University Binhai Hospital
UNKNOWN
Tianjin Nankai Hospital
OTHER
Tianjin Medical University Second Hospital
OTHER
Tianjin Medical University General Hospital
OTHER
China-Japan Friendship Hospital
OTHER
Beijing Hospital
OTHER_GOV
Shanxi Province Cancer Hospital
OTHER
Shanxi Provincial People's Hospital
OTHER_GOV
The First Affiliated Hospital of Shanxi Medical University
OTHER
Second Hospital of Shanxi Medical University
OTHER
Shengjing Hospital
OTHER
Hebei General Hospital
OTHER
First Affiliated Hospital of Harbin Medical University
OTHER
The Third Affiliated Hospital of Harbin Medical University
OTHER
Tianjin Third Central Hospital
OTHER
Responsible Party
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Principal Investigators
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Xiang Jing, MD
Role: STUDY_DIRECTOR
Tianjin Third Central Hospital
Locations
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Tianjin Third Central Hospital
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Xiang Jing, MD
Role: primary
Yan Zhou, MD
Role: backup
Other Identifiers
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drjingxiang004
Identifier Type: -
Identifier Source: org_study_id