Breast CancerNCT02661204
Diagnostic Performance of an Automated Breast Ultrasound System (ABUS)
An observational study of Breast Cancer and Implants, run by University of Zurich at 1 site in Switzerland.
Trial summary
The purpose of this study is to evaluate the diagnostic performance of a new ABUS system among 4 different population: Population A: women undergoing screening for familial or genetic predisposition for breast cancer. Population B: women with newly diagnosed breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Implants
- What is being tested?
- Automated breast ultrasound examination (ABUS)
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2016to Oct 2023
- Phase
- Observational
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Population A: women in the age range of 20 to 40 years, with a strong family history of breast cancer or a predisposing gene mutation such as BRCA1 or BRCA2. A total of 100 patients should be enrolled. Population B: women with new breast cancer diagnosis undergoing pre-operative local cancer staging.A total of 50 patients will be enrolled. Population C: women with lesions classified BI-RADS 3 or 4 in a routine breast imaging examination. A total of 50 patients will be enrolled. Population D: women undergoing breast-MRI for the evaluation of breast implants integrity. A total of 50 patients will be enrolled.
Who may be able to join
- Population A - Inclusion criteria:
- Age between 20 and 40 years
- family history of breast cancer or a proved predisposing gene mutation such as BRCA1 or BRCA2
- Population B - Inclusion criteria
- Age ≥ 18 years
- Newly diagnosed breast cancer with no previous history of breast cancer
Show all 15Show fewer
- Availability of pre-operative breast MRI performed for local staging within 4 weeks before the surgery
- Breast surgery performed at the UniversitätsSpital Zürich
- Population C - Inclusion criteria
- Age ≥ 18 years
- Newly detected BI-RADS 3 or 4 lesion
- Availability of follow-up examination or histological results of biopsy and surgery
- Population D - Inclusion criteria
- Age ≥ 18 years
- Availability of breast MRI performed for evaluating breast implants integrity
Who cannot join
- 1) Population A - Exclusion criteria:
- Personal history of breast or ovarian cancer
Trial locations and contacts
1 site in 1 country.
Andreas Boss, MD contact
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich, Institute of Diagnostic and Interventional Radiology, University Hospital Zurich
Zurich, 8091
Andreas Boss, MD, +41442553677, andreas.boss@usz.ch
About this study
Official title: Diagnostic Performance of an Automated Breast Ultrasound System (ABUS): a Single Centre Study
The purpose of this study is to evaluate the diagnostic performance of a new ABUS system among 4 different population:
Population A: women undergoing screening for familial or genetic predisposition for breast cancer.
Population B: women with newly diagnosed breast cancer. ABUS performance will be compared to breast MRI in the pre-operative assessment of breast cancer extent.
Population C: women with BI-RADS 3 or 4 lesions in a routine breast imaging examination. ABUS will be evaluate as a problem-solving tool.
Population D: women undergoing breast MRI for the assessment of breast implants integrity. ABUS performance will be compared to breast MRI.
Read the detailed description
Population A: women in the age range of 20 to 40 years, with a strong family history of breast cancer or a predisposing gene mutation such as BRCA1 or BRCA2. A total of 100 patients should be enrolled.
Population B: women with new breast cancer diagnosis undergoing pre-operative local cancer staging.A total of 50 patients will be enrolled.
Population C: women with lesions classified BI-RADS 3 or 4 in a routine breast imaging examination. A total of 50 patients will be enrolled.
Population D: women undergoing breast-MRI for the evaluation of breast implants integrity. A total of 50 patients will be enrolled.
The expected duration of subject participation is 5 years for population A: every year the patients will undergo ABUS examination and the results will be compared with HHUS examination.
In population B, C and D only one examination will be performed and the data obtained with ABUS will be compared with HH-US and breast MRI data.
Images will be evaluated by a radiologist with breast imaging experience and ABUS findings will be compared with findings from HHUS and MR imaging.
Afterwards, two or three readers (radiologists with different levels of experience in breast imaging) blinded to clinical, HH-US and MRI data, will evaluate the interobserver agreement ABUS images will be evaluated by Methods of minimising bias Population A - During the recruitment, family history of breast cancer will be in-depth analysed in order to avoid the bias related to different levels of risk for breast cancer. In order to reduce the loss of patients to follow-up, women will be invited every year to undergo HHUS and ABUS examination at our department.
- Conditions
- Breast Cancer, Implants
- Being tested
- Automated breast ultrasound examination (ABUS)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated breast ultrasound examination (ABUS)Device
Automated breast ultrasound examination
| Study group | Role | What they receive |
|---|---|---|
| Population A | Consecutive women in the age range 20 to 40 years, with a strong family history of breast cancer or a predisposing gene mutation such as BRCA1 or BRCA2, referring to our department for breast evaluation with ultrasound, will be invited to participate to the study. During the interview, before imaging examination, women will be questioned about family history as well as other relevant personal information (e.g. previous surgery or biopsy for benign breast disease). Receives: Device: Automated breast ultrasound examination (ABUS) | |
| Population B | Consecutive women with a new breast cancer diagnosis and undergoing pre-operative MRI examination for local staging will be invited to participate to the study. ABUS will be performed within two weeks before the scheduled surgery. Receives: Device: Automated breast ultrasound examination (ABUS) | |
| Population C | Consecutive women with BI-RADS 3 and 4 lesions detected in a routine breast imaging examination will be invited to participate to the study. ABUS will be performed just after the routine HH-US examination. Receives: Device: Automated breast ultrasound examination (ABUS) | |
| Population D | Consecutive women undergoing breast MRI examination for the evaluation of breast implants integrity will be invited to participate to the study. ABUS will be performed just after the breast MRI. Receives: Device: Automated breast ultrasound examination (ABUS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Population A: comparison between ABUS and HHUS with respect to the number of lesions detected with the two devices and their characterization according to the BI-RADS lexicon
Measured: 5 years
Population B:comparison between ABUS and breast MRI with respect to known malignant lesion/s size assessment and number of additional lesions detected and not previously evident with mammography and HHUS
sensitivity and specificity of a new ABUS system in the assessment of breast cancer extent. Breast MRI will be used as standard of reference
Measured: 5 years
Population C: number of patients with diagnosis of BI-RADS 3 and 4 breast lesions with ABUS compared to histological results or follow-up
sensitivity and specificity of a new ABUS system in the assessment of BI-RADS 3 and 4 lesions. Follow-up and histological results of the biopsy or surgery will be used as standard of reference
Measured: 5 years
Population D: number of participants with suspected rupture of breast implants diagnosed with ABUS compared to breast MRI diagnosis
sensitivity and specificity of a new ABUS system in the assessment of breast implants integrity. Breast MRI will be used as standard of reference
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionMay 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreas Boss, MD, Principal investigator, University Hospital Zurich, Institute of Diagnostic and Interventional Radiology, University Hospital Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02661204
- Sponsor's protocol ID
- BASEC 2015-00011
- Status last verified
- Nov 2022
- First submitted
- 13 Jan 2016
- Last updated
- 2 Nov 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance of an Automated Breast Ultrasound System (ABUS): a Single Centre Study
- ClinicalTrials.gov ID
- NCT02661204
- Acronym / sponsor ID
- BASEC 2015-00011
- Conditions
- Breast Cancer, Implants
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- May 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 22 Jan 2016 (estimated)
- 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.
The purpose of this study is to evaluate the diagnostic performance of a new ABUS system among 4 different population:
Population A: women undergoing screening for familial or genetic predisposition for breast cancer.
Population B: women with newly diagnosed breast cancer. ABUS performance will be compared to breast MRI in the pre-operative assessment of breast cancer extent.
Population C: women with BI-RADS 3 or 4 lesions in a routine breast imaging examination. ABUS will be evaluate as a problem-solving tool.
Population D: women undergoing breast MRI for the assessment of breast implants integrity. ABUS performance will be compared to breast MRI.
Detailed description
Population A: women in the age range of 20 to 40 years, with a strong family history of breast cancer or a predisposing gene mutation such as BRCA1 or BRCA2. A total of 100 patients should be enrolled.
Population B: women with new breast cancer diagnosis undergoing pre-operative local cancer staging.A total of 50 patients will be enrolled.
Population C: women with lesions classified BI-RADS 3 or 4 in a routine breast imaging examination. A total of 50 patients will be enrolled.
Population D: women undergoing breast-MRI for the evaluation of breast implants integrity. A total of 50 patients will be enrolled.
The expected duration of subject participation is 5 years for population A: every year the patients will undergo ABUS examination and the results will be compared with HHUS examination.
In population B, C and D only one examination will be performed and the data obtained with ABUS will be compared with HH-US and breast MRI data.
Images will be evaluated by a radiologist with breast imaging experience and ABUS findings will be compared with findings from HHUS and MR imaging.
Afterwards, two or three readers (radiologists with different levels of experience in breast imaging) blinded to clinical, HH-US and MRI data, will evaluate the interobserver agreement ABUS images will be evaluated by Methods of minimising bias Population A - During the recruitment, family history of breast cancer will be in-depth analysed in order to avoid the bias related to different levels of risk for breast cancer. In order to reduce the loss of patients to follow-up, women will be invited every year to undergo HHUS and ABUS examination at our department.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Population A | – | Device: Automated breast ultrasound examination (ABUS)Consecutive women in the age range 20 to 40 years, with a strong family history of breast cancer or a predisposing gene mutation such as BRCA1 or BRCA2, referring to our department for breast evaluation with ultrasound, will be invited to participate to the study. During the interview, before imaging examination, women will be questioned about family history as well as other relevant personal information (e.g. previous surgery or biopsy for benign breast disease). |
| Population B | – | Device: Automated breast ultrasound examination (ABUS)Consecutive women with a new breast cancer diagnosis and undergoing pre-operative MRI examination for local staging will be invited to participate to the study. ABUS will be performed within two weeks before the scheduled surgery. |
| Population C | – | Device: Automated breast ultrasound examination (ABUS)Consecutive women with BI-RADS 3 and 4 lesions detected in a routine breast imaging examination will be invited to participate to the study. ABUS will be performed just after the routine HH-US examination. |
| Population D | – | Device: Automated breast ultrasound examination (ABUS)Consecutive women undergoing breast MRI examination for the evaluation of breast implants integrity will be invited to participate to the study. ABUS will be performed just after the breast MRI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population A: women in the age range of 20 to 40 years, with a strong family history of breast cancer or a predisposing gene mutation such as BRCA1 or BRCA2. A total of 100 patients should be enrolled. Population B: women with new breast cancer diagnosis undergoing pre-operative local cancer staging.A total of 50 patients will be enrolled. Population C: women with lesions classified BI-RADS 3 or 4 in a routine breast imaging examination. A total of 50 patients will be enrolled. Population D: women undergoing breast-MRI for the evaluation of breast implants integrity. A total of 50 patients will be enrolled.
Key inclusion criteria (15 listed)
- Population A - Inclusion criteria:
- Population B - Inclusion criteria
- Population C - Inclusion criteria
- Population D - Inclusion criteria
Key exclusion criteria (2 listed)
- Personal history of breast or ovarian cancer
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 examination (ABUS)Automated breast ultrasound examination | Device | Population A, Population B, Population C, Population D |
Primary outcome
Population A: comparison between ABUS and HHUS with respect to the number of lesions detected with the two devices and their characterization according to the BI-RADS lexicon
Time frame: 5 years
Population B:comparison between ABUS and breast MRI with respect to known malignant lesion/s size assessment and number of additional lesions detected and not previously evident with mammography and HHUS
Time frame: 5 years
sensitivity and specificity of a new ABUS system in the assessment of breast cancer extent. Breast MRI will be used as standard of reference
Population C: number of patients with diagnosis of BI-RADS 3 and 4 breast lesions with ABUS compared to histological results or follow-up
Time frame: 5 years
sensitivity and specificity of a new ABUS system in the assessment of BI-RADS 3 and 4 lesions. Follow-up and histological results of the biopsy or surgery will be used as standard of reference
Population D: number of participants with suspected rupture of breast implants diagnosed with ABUS compared to breast MRI diagnosis
Time frame: 5 years
sensitivity and specificity of a new ABUS system in the assessment of breast implants integrity. Breast MRI will be used as standard of reference
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
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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.
Andreas Boss, MD contact
Andreas Boss, MD principal investigator
University Hospital Zurich, Institute of Diagnostic and Interventional Radiology, University Hospital Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Implants, run by University of Zurich at 1 site in Switzerland.
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 15 inclusion and 2 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 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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 Andreas Boss, MD (andreas.boss@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Population A: comparison between ABUS and HHUS with respect to the number of lesions detected with the two devices and their characterization according to the BI-RADS lexicon (time frame: 5 years). The study lists 4 primary outcomes in all. 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 2 Nov 2022; AzTrials last refreshed its copy on 7 Nov 2026.