Early Stage Breast CancerNCT04607473
ABUS for Early-stage Breast Cancer
A study testing automated breast ultrasound (ABUS) in people with Early Stage Breast Cancer, run by Samsung Medical Center at 3 sites in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 69 years, women only
- Conditions the study is for
- Early Stage Breast Cancer
- What is being tested?
- automated breast ultrasound (ABUS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 675 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 15 Aug 2019to 15 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 69 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites, 3 recruiting
- Recruiting
Department of Radiology, Konkuk University Medical Center, Konkuk University School of Medicine
Seoul, 05030
Nami Choi, MD, PhD, 82-10-3561-3243, nami0119@gmail.com
- Recruiting
Samsung Medical Center
Seoul, 06351
Ji Soo Choi, MD,PhD, 82-2-3410-3902, jisoo.choi@samsung.com
- Recruiting
Department of Radiology Ewha womans university medical center
Seoul, 07985
Jin Chung, MD, PhD, 82-10-8860-4270, aqua0724@ewha.ac.kr
About this study
Official title: 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.
- Conditions
- Early Stage Breast Cancer
- Being tested
- automated breast ultrasound (ABUS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
automated breast ultrasound (ABUS)Device
Also called hand-held ultrasound (HHUS)
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.
| Study group | Role | What they receive |
|---|---|---|
| ABUS | Experimental | 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. Receives: Device: automated breast ultrasound (ABUS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 year
Secondary outcomes (1)
Agreement between tumor size measurements
Agreement between tumor size measurements by ABUS and HHUS and pathologic tumor size
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start15 Aug 2019
- Primary completion30 Mar 2021 (estimated)
- Study completion15 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Stage Breast CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 675 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Soo Choi, Samsung Medical Center
- Investigators
- Ji Soo Choi, MD,PhD, Principal investigator, Samsung Medical Center, Department of Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04607473
- Sponsor's protocol ID
- GRO-06-001
- Status last verified
- Oct 2020
- First submitted
- 18 Oct 2020
- Last updated
- 30 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of ABUS and HHUS in Preoperative Evaluation of Patients With Early-stage Breast Cancers
- ClinicalTrials.gov ID
- NCT04607473
- Acronym / sponsor ID
- GRO-06-001
- Conditions
- Early Stage Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 675 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 30 Mar 2021 (estimated)
- Study completion
- 15 Aug 2022 (estimated)
- First posted
- 29 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ABUS | Experimental | Device: automated breast ultrasound (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. |
Who may qualify
- Ages
- 25 to 69 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| automated breast ultrasound (ABUS)Also: hand-held ultrasound (HHUS)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. | Device | ABUS |
Primary outcome
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
1 secondary outcome
Agreement between tumor size measurements
Time frame: 3 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ji Soo Choi, MD,PhD principal investigator
Samsung Medical Center, Department of Radiology
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing automated breast ultrasound (ABUS) in people with Early Stage Breast Cancer, run by Samsung Medical Center at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ji Soo Choi, MD,PhD (82-2-3410-3902, jisoo.choi@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performances of ABUS and HHUS (time frame: 3 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2020.