Sonazoid Contrast-enhanced Ultrasound in Assessing Effect... | NCT04657341

Studies
Sonazoid Contrast-enhanced Ultrasound in Assessing Effectiveness of Neoadjuvant Chemotherapy in Breast Cancer Patients.

NCT04657341

Sponsor

Chinese PLA General Hospital

Status

Unknown status

Last Update Posted

Dec 8, 2020Actual

Enrollment

1,012Estimated

Phase

Not provided

Conditions

Ultrasound

Interventions

Not provided

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

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2020Actual

Primary Completion Date

Mar 2021Estimated

Completion Date

Dec 2021Estimated

First Submitted Date

Sep 26, 2020

First Submission Date that Met QC Criteria

Dec 5, 2020

First Posted Date

Dec 8, 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 5, 2020

Last Update Posted Date

Dec 8, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Sonazoid as a new generation of ultrasound contrast agent.This study based on the features of Sonazoid specific angiography and high mechanical index,the role of Sonazoid in assessing effectiveness of neoadjuvant chemotherapy in breast cancer patients was explored.

Detailed Description

This is a prospective, multicenter study.More than 1000 participants will enrolled.Most of them with CEUS,MRI and pathological follow up.When enhanced MRI is needed in the neoadjuvant cycle of patients, Sonazoid-CEUS examination is added at this time point, and postoperative pathology will be used as the gold standard, so as to compare the ability of the two imaging examinations in judging the effect of neoadjuvant chemotherapy.

Investigators will also record the parameter information of imaging examination, pathological type of pathological examination and immunohistochemical index, etc.Contrast-enhanced ultrasound includes lesion location, initial peak tumor volume, 1-minute tumor volume, 2-minute tumor volume, and 5-minute tumor volume, as well as the time for contrast enhancement, contrast agent clearance, and contrast agent clearance.Whether there is no enhancement area in the lesion after contrast enhancement, shape after contrast enhancement, edge after contrast enhancement, order of enhancement, uniformity of enhancement, intensity enhancement, pattern of enhancement, clear boundary after contrast enhancement, aspect ratio after contrast enhancement, etc.The magnetic field strength of the equipment is planned to be recorded in the enhanced MRI information, the name of the MRI contrast agent, the lesion location, the size of the lesion, and the scanning performance are enhanced (lump-like enhancement, non-lump-like enhancement, point-like enhancement), time-signal intensity enhancement curve, DWI signal, ADC value, etc.

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

1,012Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sonazoid contrast-enhanced ultrasound in assessing effectiveness of neoadjuvant chemotherapy in breast cancer patients.	Pathology as a gold standard,to compare the diagnostic performance between contrast-enhanced ultrasound and other contrast-enhanced imaging in neoadjuvant chemotherapy in breast cancer patients.	10 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

(1) Refer to the guidelines and specifications for diagnosis and treatment of breast cancer, and it is clearly identified as breast cancer by pathological biopsy.
(2) Plan to implement NAC therapy;
(3) All patients and their family members signed informed consent forms, which were approved by the hospital medical Ethics Committee

Exclusion Criteria:

(1) Those who are known to be allergic to ultrasound contrast agents;
(2)The subject has a history of allergy to eggs or egg products (i.e. skin rash, dyspnea, swelling of the mouth or throat, hypotension or shock, etc.)
(3) Intolerance to neoadjuvant chemotherapy;
(4) Poor compliance with chemotherapy treatment;
(5) Patients who cannot receive contrast agent MRI examination
(6) Arteriovenous (left and right) shunt patients in the heart and lungs;
(7) Mental disorders or mental disorders;
(8)Patients with serious heart disease or lung disease;
(9)Pet-pregnant, possibly pregnant or lactating;
(10)In addition, the researcher or the researcher thinks that the patient is not suitable to participate in this study.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Breast cancer patients who plan neoadjuvant chemotherapy and conform to contrast-enhanced ultrasound, enhanced mri, and surgical indications.

Sampling Method

Probability Sample