PCR Based CEUS in BI RADS 4A Nodules

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04929054
• Collaborator: Beijing Friendship Hospital (Other)
• Enrollment: 260
• Location: 1
• Anticipated Duration (Months): 33
• Patients Per Site Per Month: 7.9

Study Details

Study Description

Brief Summary

The aim of this study was to investigate the added value of Principal Component Regression (PCR) based contrast-enhanced ultrasound (CEUS) for differentiating low risk patients with breast nodules categorized as 4A using the Breast Imaging Reporting and Data System (BI-RADS).

Condition or Disease	Intervention/Treatment	Phase
PCA; Breast Cancer	Diagnostic Test: imaging

Detailed Description

The aim of this study was to investigate the added value of Principal Component Regression (PCR) based contrast-enhanced ultrasound (CEUS) for differentiating low risk patients with breast nodules categorized as 4A using the Breast Imaging Reporting and Data System (BI-RADS). The study included patients with 4A nodules confirmed by core biopsy and/or surgery. The CEUS parameters were assessed and PCR scores were calculated to evaluated the added value in BI-RADS 4A nodules.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 260 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Principal Component Regression Based Contrast Enhanced Ultrasound Evaluating System in the Management of BI-RADS 4A Breast Nodules
• Actual Study Start Date: Apr 1, 2019
• Actual Primary Completion Date: May 30, 2020
• Anticipated Study Completion Date: Dec 30, 2021

Outcome Measures

Primary Outcome Measures

1. surgery or biopsy [up to 3 months]

   According to the PCR result, if it's positive, the nodule category was maintained, however, if it's negative, the nodule was downgraded. all nodules were submitted to biopsy or biopsy.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

patients with BI-RADS 4A breast lesion

Exclusion Criteria:

(i) absence of a pathologic diagnosis; (ii) presence of breast nodules that were too large to compare with normal parenchyma; (iii) patients with radiotherapy and chemotherapy of breast cancer; and (iv) skin disorders.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SAHZJU	Hanzhou	Zhejiang	China	310009

Sponsors and Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University
• Beijing Friendship Hospital

Investigators

• Study Chair: pintong Huang, SAHZJU

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
• ClinicalTrials.gov Identifier: NCT04929054
• Other Study ID Numbers: Breast 2019
• First Posted: Jun 18, 2021
• Last Update Posted: Jul 15, 2021
• Last Verified: Mar 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

Study Results

No Results Posted as of Jul 15, 2021