Back to resultsDiagnosis of Nodules ≤2 cm Based on US and CEUS Compared With Current Clinical Procedure
Primary Purpose
Liver Cancer, Liver Cirrhosis
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Immediate CEUS
Sponsored by
About this trial
This is an interventional diagnostic trial for Liver Cancer focused on measuring Liver Cancer, CEUS, Diagnostic Methods, Cost Optimization
Eligibility Criteria
Inclusion Criteria:
- Patients are at high risk of HCC.
- The ages of patients are between 18 and 80.
- Patients are with solid liver lesion(s) ≤ 2 cm detected by US.
- Patient signs the informed consent.
Exclusion Criteria:
- Patients are with liver cirrhosis due to congenital hepatic fibrosis or due to hepatic vascular diseases such as hereditary telangiectasia, Budd-Chiari syndrome, chronic portal vein occlusion syndrome, congestive heart disease.
- Patient's age is < 18 years old or > 80 years old.
- Patients with known hypersensitivity to CEUS, CECT, CEMRI, or hepatobiliary-specific MRI contrast agents.
- Patient is a pregnant or breastfeeding woman.
- Patient is not diagnosed based on the reference diagnostic criteria required by the study.
- Patient is considered to be unsuitable to participate in the study.
Sites / Locations
- Tianjin Third Central HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Immediate CEUS group
Current clinical procedure group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Diagnostic performance based on US and immediate CEUS with current routine
The diagnostic efficacy，including sensitivity, specificity, accurary and AUC， of the two groups for HCC from the detection of suspicious lesions by routine US screening to the final diagnosis.
Time benefits based on US and immediate CEUS with current routine
Time from the detection of suspicious lesions by routine US screening to the first diagnosis of HCC by enhanced imaging examinations and the final diagnosis of HCC.
Secondary Outcome Measures
The economic benefit based on US and immediate CEUS with current routine
The cost of imaging studies from the discovery of suspicious lesions by routine US screening to the final clinical diagnosis of HCC or the clinical diagnosis of benign lesions.
Full Information
NCT ID
NCT05360420
First Posted
March 4, 2022
Last Updated
December 11, 2022
Sponsor
Tianjin Third Central Hospital
Collaborators
Tianjin Second People's Hospital, Tianjin Medical University Cancer Institute and Hospital, Peking University Binhai Hospital, Tianjin Nankai Hospital, Tianjin Medical University Second Hospital, Tianjin Medical University General Hospital, China-Japan Friendship Hospital, Beijing Hospital, Shanxi Province Cancer Hospital, Shanxi Provincial People's Hospital, The First Affiliated Hospital of Shanxi Medical University, Second Hospital of Shanxi Medical University, Shengjing Hospital, Hebei General Hospital, First Affiliated Hospital of Harbin Medical University, The Third Affiliated Hospital of Harbin Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05360420
Brief Title
Diagnosis of Nodules ≤2 cm Based on US and CEUS Compared With Current Clinical Procedure
Official Title
Screening and Diagnosis of Nodules ≤2 cm in High-risk HCC Patients in China Based on US and CEUS: a Multicenter, Prospective, Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 26, 2022 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Third Central Hospital
Collaborators
Tianjin Second People's Hospital, Tianjin Medical University Cancer Institute and Hospital, Peking University Binhai Hospital, Tianjin Nankai Hospital, Tianjin Medical University Second Hospital, Tianjin Medical University General Hospital, China-Japan Friendship Hospital, Beijing Hospital, Shanxi Province Cancer Hospital, Shanxi Provincial People's Hospital, The First Affiliated Hospital of Shanxi Medical University, Second Hospital of Shanxi Medical University, Shengjing Hospital, Hebei General Hospital, First Affiliated Hospital of Harbin Medical University, The Third Affiliated Hospital of Harbin Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Due to different etiologies, diagnosis and treatment of HCC in China is different from that in Western countries.US is an important screening method for HCC in patients with liver cirrhosis. CEUS, as an enhanced imaging method based on US, has the advantages of convenience, non-radiation, low cost, short examination time, and the diagnostic performance of HCC is comparable to that of CECT, CEMRI, and hepatobiliary-specific MRI.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer, Liver Cirrhosis
Keywords
Liver Cancer, CEUS, Diagnostic Methods, Cost Optimization
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
6730 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Immediate CEUS group
Arm Type
Experimental
Arm Description
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.
Arm Title
Current clinical procedure group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Immediate CEUS
Intervention Description
Subjects will receive CEUS examination immediately for the suspicious lesion detected by US.
Primary Outcome Measure Information:
Title
Diagnostic performance based on US and immediate CEUS with current routine
Description
The diagnostic efficacy，including sensitivity, specificity, accurary and AUC， of the two groups for HCC from the detection of suspicious lesions by routine US screening to the final diagnosis.
Time Frame
6 to 12 months
Title
Time benefits based on US and immediate CEUS with current routine
Description
Time from the detection of suspicious lesions by routine US screening to the first diagnosis of HCC by enhanced imaging examinations and the final diagnosis of HCC.
Time Frame
6 to 12 months
Secondary Outcome Measure Information:
Title
The economic benefit based on US and immediate CEUS with current routine
Description
The cost of imaging studies from the discovery of suspicious lesions by routine US screening to the final clinical diagnosis of HCC or the clinical diagnosis of benign lesions.
Time Frame
6 to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients are at high risk of HCC.
The ages of patients are between 18 and 80.
Patients are with solid liver lesion(s) ≤ 2 cm detected by US.
Patient signs the informed consent.
Exclusion Criteria:
Patients are with liver cirrhosis due to congenital hepatic fibrosis or due to hepatic vascular diseases such as hereditary telangiectasia, Budd-Chiari syndrome, chronic portal vein occlusion syndrome, congestive heart disease.
Patient's age is < 18 years old or > 80 years old.
Patients with known hypersensitivity to CEUS, CECT, CEMRI, or hepatobiliary-specific MRI contrast agents.
Patient is a pregnant or breastfeeding woman.
Patient is not diagnosed based on the reference diagnostic criteria required by the study.
Patient is considered to be unsuitable to participate in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiang Jing, MD
Phone
02284112323
Ext
+86
Email
dr.jingxiang@aliyun.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Zhou, MD
Phone
02284118101
Ext
+86
Email
zhouyan2626@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiang Jing, MD
Organizational Affiliation
Tianjin Third Central Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Tianjin Third Central Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300170
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiang Jing, MD
Phone
02284112323
Ext
+86
Email
dr.jingxiang@aliyun.com
First Name & Middle Initial & Last Name & Degree
Yan Zhou, MD
Phone
02284118101
Ext
+86
Email
zhouyan2626@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Diagnosis of Nodules ≤2 cm Based on US and CEUS Compared With Current Clinical Procedure
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