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

NCT ID: NCT04686942

Last Updated: 2020-12-29

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

550 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-17

Study Completion Date

2023-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Liver Metastasis Colon Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Before sonazoid

US detection liver metastases before sonazoid

No interventions assigned to this group

After sonazoid

US detection liver metastases after sonazoid

After sonazoid

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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After sonazoid

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Yunfei Yuan

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yunfei Yuan, MD.

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

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Sun Yat-sen University Cancer Center

Guangzhou, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jiliang Qiu

Role: CONTACT

Phone: 862087343114

Email: [email protected]

Xuzhi Pan

Role: CONTACT

Phone: 862087343009

Email: [email protected]

Facility Contacts

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Jiliang Qiu

Role: primary

Xuzhi Pan

Role: backup

Other Identifiers

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Sonazoid001

Identifier Type: -

Identifier Source: org_study_id