Sonazoid-enhanced Ultrasound for the Detection of Colorec... | NCT04686942

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

NCT04686942

Sponsor

Sun Yat-sen University

Status

Unknown status

Last Update Posted

Dec 29, 2020Actual

Enrollment

550Estimated

Phase

Not provided

Conditions

Liver Metastasis Colon Cancer

Interventions

After sonazoid

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 17, 2020Actual

Primary Completion Date

Dec 30, 2022Estimated

Completion Date

Dec 30, 2023Estimated

First Submitted Date

Dec 20, 2020

First Submission Date that Met QC Criteria

Dec 27, 2020

First Posted Date

Dec 29, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 27, 2020

Last Update Posted Date

Dec 29, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

550Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Before sonazoid		US detection liver metastases before sonazoid
After sonazoid		US detection liver metastases after sonazoid	Diagnostic Test: After sonazoid

Interventions

Name	Type	Description	Arm Group Labels	Other Names
After sonazoid	Diagnostic Test	0.015ml/mg sonazoid enhanced US to detection of liver metastases.	After sonazoid

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jiliang Qiu	Contact	862087343114		qiujl@sysucc.org.cn
Xuzhi Pan	Contact	862087343009		panxzh@sysucc.org.cn

Overall Officials

Name	Affiliation	Role
Yunfei Yuan, MD.	Sun Yat-sen University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sun Yat-sen University Cancer Center	Recruiting	Guangzhou			China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided