- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04607473
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
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
675
Phase
- 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
- Name: Ji Soo Choi, MD,PhD
- Phone Number: 82-2-3410-3902
- Email: jisoo.choi@samsung.com
Study Locations
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-
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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
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Seoul, Korea, Republic of, 05030
- Recruiting
- Department of Radiology, Konkuk University Medical Center, Konkuk University School of Medicine
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Contact:
- Nami Choi, MD, PhD
- Phone Number: 82-10-3561-3243
- Email: nami0119@gmail.com
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Seoul, Korea, Republic of, 07985
- Recruiting
- Department of Radiology Ewha womans university medical center
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Contact:
- Jin Chung, MD, PhD
- Phone Number: 82-10-8860-4270
- Email: aqua0724@ewha.ac.kr
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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
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 |
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.
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnostic performances of ABUS and HHUS
Time Frame: 3 year
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The sensitivities and specificity of each US mode for the detection of breast cancers are calculated on a per-lesion basis
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3 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Agreement between tumor size measurements
Time Frame: 3 year
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Agreement between tumor size measurements by ABUS and HHUS and pathologic tumor size
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3 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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)
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
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
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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