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

December 27, 2020 updated by: Yunfei Yuan, Sun Yat-sen University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

550

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Guangzhou, China
        • Recruiting
        • Sun Yat-Sen University Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with one or more liver metastases lesions less than 2cm.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Before sonazoid
US detection liver metastases before sonazoid
After sonazoid
US detection liver metastases after sonazoid
Diagnostic test: After sonazoid
0.015ml/mg sonazoid enhanced US to detection of liver metastases.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sensitive of detection tumor
Time Frame: 6 months
Change of the sensitivity detection liver tumors when using sonazoid enhanced ultrasound
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 17, 2020

Primary Completion (Anticipated)

December 30, 2022

Study Completion (Anticipated)

December 30, 2023

Study Registration Dates

First Submitted

December 20, 2020

First Submitted That Met QC Criteria

December 27, 2020

First Posted (Actual)

December 29, 2020

Study Record Updates

Last Update Posted (Actual)

December 29, 2020

Last Update Submitted That Met QC Criteria

December 27, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sonazoid001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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