NCT04686942

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
550

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 17, 2020

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

December 20, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 29, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

December 29, 2020

Status Verified

December 1, 2020

Enrollment Period

2 years

First QC Date

December 20, 2020

Last Update Submit

December 27, 2020

Conditions

Liver Metastasis Colon Cancer

Outcome Measures

Primary Outcomes (1)

  • sensitive of detection tumor

    Change of the sensitivity detection liver tumors when using sonazoid enhanced ultrasound

    6 months

Study Arms (2)

Before sonazoid

US detection liver metastases before sonazoid

After sonazoid

US detection liver metastases after sonazoid

Diagnostic Test: After sonazoid

Interventions

After sonazoidDIAGNOSTIC_TEST

0.015ml/mg sonazoid enhanced US to detection of liver metastases.

After sonazoid

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Could not fulfill the criteria of no evidence of disease (NED) after hepatic resection/ablation/radiotherapy
  • With other malignancies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, China

RECRUITING

Study Officials

  • Yunfei Yuan, MD.

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiliang Qiu

CONTACT

862087343114qiujl@sysucc.org.cn

Xuzhi Pan

CONTACT

862087343009panxzh@sysucc.org.cn

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 20, 2020

First Posted

December 29, 2020

Study Start

December 17, 2020

Primary Completion

December 30, 2022

Study Completion

December 30, 2023

Last Updated

December 29, 2020

Record last verified: 2020-12

Locations

CN(1)