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NCT04686942 Clinical Trial

Sonazoid-enhanced Ultrasound for the Detection of Colorectal Liver Metastases Less Than 2 cm

Liver Metastasis Colon Cancer Clinical Trial

Official title:
Evaluation of Contrast Sonazoid-enhanced Ultrasound for the Detection of Colorectal Liver Metastases Less Than 2 cm

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04686942
Other study ID # Sonazoid001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 17, 2020
Est. completion date December 30, 2023

Study information
Verified date December 2020
Source Sun Yat-sen University
Contact Jiliang Qiu
Phone 862087343114
Email qiujl@sysucc.org.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Preoperative chemotherapy is often used for patients with colorectal cancer liver metastasis (CLM). Many small CLMs (<=2cm) may disappear after chemotherapy, while most of these are still alive. Ultrasonography (US) is a common imaging modality for the intraoperative detection tumor. Sonazoid is new echo-contrast agent, which is more stable and sensitive for detecting of small tumor. Investigators initially this prospective study to compare the detection performance before and after using sonazoid.

Recruitment information / eligibility
Status Recruiting
Enrollment 550
Est. completion date December 30, 2023
Est. primary completion date December 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - Pathology confirmed colorectal adenocarcinoma - One or more liver metastases less than 2 cm - Multidisciplinary team recommend to perform preoperative chemotherapy - Have baseline EOB-MR before chemotherapy Exclusion Criteria: - Could not fulfill the criteria of no evidence of disease (NED) after hepatic resection/ablation/radiotherapy - With other malignancies

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• After sonazoid
0.015ml/mg sonazoid enhanced US to detection of liver metastases.

Locations
Country Name City State
China Sun Yat-sen University Cancer Center Guangzhou

Sponsors (1)
Lead Sponsor Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary sensitive of detection tumor Change of the sensitivity detection liver tumors when using sonazoid enhanced ultrasound 6 months
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