ABUS for Early-stage Breast Cancer

Comparison of ABUS and HHUS in Preoperative Evaluation of Patients With Early-stage Breast Cancers

While the role of automated breast ultrasound (ABUS) as an alternative to hand-held ultrasound (HHUS) in breast cancer screening has been established, the use of ABUS in preoperative evaluation of newly diagnosed breast cancer patients is still limited. This may be because axillary areas are not included in the scanning area of ABUS. Newly diagnosed breast cancer patients have undergone axillary US to predict axillary lymph node metastasis before surgery, in combination with preoperative breast US, in many institutions. However, recent studies have reported that sentinel lymph node biopsy alone is sufficient for diagnosis and treatment of axillae of patients with early-stage breast cancer, because the incidence of axillary lymph node metastasis is very low. Therefore, the clinical significance of preoperative axillary US is being lowered in patients with early-stage breast cancers. Thus, considering that coronal images provided by ABUS may be more advantageous for detection of multifocal or multicentric cancer, we hypothesized that ABUS could replace HHUS in preoperative staging of patients with early-stage breast cancers (clinical Tis, T1-2/N0 cancers) for whom preoperative axillary US is not necessary. The purpose of this study was to prospectively compare the diagnostic performances of ABUS and HHUS in preoperative evaluation of patients with early-stage breast cancers. This study will be conducted with institutional review board approval, and written informed consent will be obtained. From the Jan 2019 to Dec 2021, 675 patients diagnosed with early-stage breast cancer will be enrolled from the three institutions. Both ABUS and HHUS will be performed on each patient before surgery. Breast radiologists independently review ABUS and HHUS images. They detect all visible lesions and record the location and size of them. They characterize all detected lesions by using BI-RADS category. The primary object is to compare the diagnostic performance of ABUS and HHUS as preoperative staging tool in women with known breast cancers. The sensitivities and specificity of each US mode for the detection of breast cancers are calculated on a per-lesion basis. McNemar's test and Fisher's exact test are used to compare the sensitivities and PPVs for ABUS and HHUS. Significance testing on the lesion level and patient level is conducted using generalized estimating equations (GEEs) with a logit link and an independent working correlation structure to adjust the effect of clustering on radiologists and patients. GEEs are utilized to compare the sensitivities and PPVs for ABUS and HHUS. Diagnostic performance are assessed with receiver operating characteristics curve analysis. Area under the curves are calculated from both parametric and trapezoidal curve fitting. Agreements between tumor size measured by each US mode and pathologic the tumor size are analyzed with the intraclass correlation coefficient (ICC) and 95% Bland-Altman limits of agreement.

Study Overview

• Status: Unknown
• Conditions: Early Stage Breast Cancer
• Intervention / Treatment: Device: automated breast ultrasound (ABUS)

• Study Type: Interventional
• Enrollment (Anticipated): 675
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06351
    • Recruiting
    • Samsung Medical Center
    • Contact: Ji Soo Choi, MD,PhD; Phone Number: 82-2-3410-3902; Email: jisoo.choi@samsung.com
  • Seoul, Korea, Republic of, 05030
    • Recruiting
    • Department of Radiology, Konkuk University Medical Center, Konkuk University School of Medicine
    • Contact: Nami Choi, MD, PhD; Phone Number: 82-10-3561-3243; Email: nami0119@gmail.com
  • Seoul, Korea, Republic of, 07985
    • Recruiting
    • Department of Radiology Ewha womans university medical center
    • Contact: Jin Chung, MD, PhD; Phone Number: 82-10-8860-4270; Email: aqua0724@ewha.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Patients with early-stage breast cancer (clinical Tis, T1- T2 cancers are suspected on mammography at the time of diagnosis), without palpable nodes at physical examination (N0)
• Patients who schedule to undergo surgery and sentinel lymph node biopsy
• Patient's age between 25-69 years
• Patients who voluntarily agree to participate in this study

Exclusion Criteria:

• A history of previously treated breast cancers
• Patients who undergo excision biopsy for diagnosed breast cancer
• Pregnant or lactating women
• Patients who have breast implants

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: ABUS; ABUS is performed by experienced technicians using a GE inveniaTM. Each breast is imaged in three views with an automated 15.4-cm 14-6-MHz linear- array transducer, which acquires up to 1000 two-dimensional images in the transverse plane, imaging the breast in three parts: the central (anteroposterior), lateral, and medial portions of the breast. To ensure inclusion of all breast tissue, particularly in participants with very large breasts, additional views are obtained as deemed necessary by the technician to cover the entirety of the breast.

Device: automated breast ultrasound (ABUS); Both HHUS and ABUS will be performed on each patient for preoperative staging. Breast radiologists each independently will read HHUS and ABUS images obtained from one patient. The radiologists will be blinded to the findings of the other US mode.; Other Names: hand-held ultrasound (HHUS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic performances of ABUS and HHUS	The sensitivities and specificity of each US mode for the detection of breast cancers are calculated on a per-lesion basis	3 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Agreement between tumor size measurements	Agreement between tumor size measurements by ABUS and HHUS and pathologic tumor size	3 year

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Principal Investigator: Ji Soo Choi, MD,PhD, Samsung Medical Center, Department of Radiology

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2019
• Primary Completion (Anticipated): March 30, 2021
• Study Completion (Anticipated): August 15, 2022

Study Registration Dates

• First Submitted: October 18, 2020
• First Submitted That Met QC Criteria: October 22, 2020
• First Posted (Actual): October 29, 2020

Study Record Updates

• Last Update Posted (Actual): October 30, 2020
• Last Update Submitted That Met QC Criteria: October 29, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: GRO-06-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No