ABUS for Early-stage Breast Cancer

October 29, 2020 updated by: Ji Soo Choi, Samsung Medical Center

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
675

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 06351
        • Recruiting
        • Samsung Medical Center
        • Contact:
      • Seoul, Korea, Republic of, 05030
        • Recruiting
        • Department of Radiology, Konkuk University Medical Center, Konkuk University School of Medicine
        • Contact:
      • Seoul, Korea, Republic of, 07985
        • Recruiting
        • Department of Radiology Ewha womans university medical center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Diagnostic performances of ABUS and HHUS
Time Frame: 3 year
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Agreement between tumor size measurements
Time Frame: 3 year
Agreement between tumor size measurements by ABUS and HHUS and pathologic tumor size
3 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Samsung Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ji Soo Choi, MD,PhD, Samsung Medical Center, Department of Radiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 15, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 18, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 29, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 30, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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