Breast CancerNCT06920108
TRACE4BUS for BI-RADS Classification
An observational study of Breast Cancer, run by DeepTrace Technologies S.r.l. at 1 site in Italy.
Trial summary
The purpose of this clinical study is to evaluate the use of the TRACE4BUS software that is proposed to support the physician in reporting the results of breast ultrasound according to the international classification standard Breast Image - Reporting and Data System (BI-RADS) of the American College of Radiology. Read more about this study
- Who is it for?
- Ages 18 to 89 years, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 590 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2025to Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 89 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with breast masses detected at ultrasound imaging and considered suspicious for breast cancer by physicians with experience in breast ultrasound.
Who may be able to join
- Retrospective study part:
- Availability of ultrasound-guided breast biopsy and, in case of B3 lesions at needle biopsy, the vacuum-assisted excision, or surgical specimens or a clinical follow-up outcome in at least 12 months subsequent to the biopsy.
- Prospective study part:
- Signed informed consent to participate in the study.
Who cannot join
- Retrospective study part:
- Not availability of ultrasound-guided breast biopsy and, in case of B3 lesions at needle biopsy, the vacuum-assisted excision, or surgical specimens, or a clinical follow-up outcome in at least 12 months subsequent to the biopsy. Age < 18 or > 89 years.
- Prospective study part:
- Not availability of Signed informed consent to participate in the study. Age < 18 or > 89 years.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Lombardy, 20133
Gianfranco Scaperrotta, +39 333 257 2380, Gianfranco.Scaperrotta@istitutotumori.mi.it
Gianfranco Scaperrotta
About this study
Official title: TRACE4BUS: Use of the TRACE4BUS Software to Support the Physician in Reporting Breast Ultrasound Results According to the International Classification Standard Breast Image - Reporting and Data System (BI-RADS)
The purpose of this clinical study is to evaluate the use of the TRACE4BUS software that is proposed to support the physician in reporting the results of breast ultrasound according to the international classification standard Breast Image - Reporting and Data System (BI-RADS) of the American College of Radiology. This classification is recommended because it reduces the risk of subjective interpretations of descriptive results and prevents these results from being interpreted differently by the physician who evaluated the ultrasound examination, the physician who may have requested the examination, the patient and the patient's trusted physician (family physician or specialist). The BI-RADS classification is based on the evaluation of the shape, size, margins and other characteristics of a possible breast abnormality identified on the ultrasound image by the physician who evaluated the ultrasound examination, characteristics that are not always easy for that physician to evaluate.
The study aims to verify if the BI-RADS classification by the physician can be supported by the TRACE4BUS software. In particular, it refers to the support that the software provides to the physician who has evaluated the ultrasound examination in assigning the BI-RADS category for an abnormality of the breast found to be suspicious by the physician on the basis of qualitative characteristics (shape, size, margins, preferential orientation with respect to the skin plane, internal homogeneity/inhomogeneity, possible acoustic barrier effect, etc.). The TRACE4BUS software, trained on the basis of hundreds of ultrasound images of suspicious breast masses with a certain diagnosis of benignity or malignancy at subsequent diagnostic investigations, performs a quantitative analysis of the ultrasound characteristics of a suspicious breast mass and proposes a BI-RADS category to the physician. In any case, the physician will have complete decision-making power in the final attribution of the BI-RADS category and in the subsequent recommendations or decisions regarding the medical management of the case.
The clinical study also aims to evaluate whether the agreement between physicians in the use of this BI-RADS classification of suspicious breast masses improves with the use of the software.
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, BI-RADS classification, Breast ultrasound
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective cohort | The investigators propose a retrospective study on patients aged ≥18 years, who have had breast masses detected on ultrasound and considered suspicious for breast cancer by physicians expert in breast ultrasound at the Breast Radiology Unit of the National Cancer Institute, Milan, Italy, from January 1, 2020 to December 31, 2021. These ultrasound images of breast masses will be those acquired in the context of ultrasound-guided core needle biopsy. | |
| Prospective cohort | The investigators propose a prospective design on consecutive patients (age > 18 years) with breast masses detected by ultrasound and considered suspicious for breast cancer by physicians with experience in breast ultrasound at the same clinic, from the approval data of the Ethics Committee until completion of the expected sample size. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specificity, positive predictive value, sensitivity and negative predictive value
Specificity, positive predictive value, sensitivity and negative predictive value before knowing the BI-RADS category proposed by the TRACE4BUS software and after being informed of the software prediction of BI-RADS category by the TRACE4BUS software.
Measured: From enrollment to biopsy up to 12-month follow-up when necessary
Secondary outcomes (3)
K-Cohen
K-Cohen to measure inter-rater agreement between two physicians before knowing the BI-RADS category proposed by the TRACE4BUS software and after being informed of the software prediction of BI-RADS category by the TRACE4BUS software
Measured: 9 months and 18 months
Number of correct answers on the use of TRACE4BUS as assessed in the training questionnaire
Number of correct answers in the training questionnaire to measure the effectiveness of the training in the use of TRACE4BUS software after one session. More than 70% (0% minimum score, 100% maximum score) of correct answers are required to demonstrate the effectiveness of the training.
Measured: From date of training in the use of TRACE4BUS software to the physicians to training efficacy questionnaire within 2 weeks
Total scores on the usability of TRACE4BUS as assessed in the usability satisfaction questionnaire
Total scores on the usability satisfaction questionnaire to measure the usability satisfaction of TRACE4BUS. More than 70% of satisfaction (0% minimum satisfaction, 100% maximum satisfaction) is required to demonstrate the satisfaction on the usability of TRACE4BUS.
Measured: 9 months and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study startApr 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionOct 2026 (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.
- 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
- Other
- Enrolment
- 590 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DeepTrace Technologies S.r.l.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06920108
- Sponsor's protocol ID
- TRACE4BUSv2.0-CIP-1
- Status last verified
- Apr 2025
- First submitted
- 26 Mar 2025
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRACE4BUS: Use of the TRACE4BUS Software to Support the Physician in Reporting Breast Ultrasound Results According to the International Classification Standard Breast Image - Reporting and Data System (BI-RADS)
- ClinicalTrials.gov ID
- NCT06920108
- Acronym / sponsor ID
- TRACE4BUSv2.0-CIP-1
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, BI-RADS classification, Breast ultrasound
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 590 participants (estimated)
- Lead sponsor
- DeepTrace Technologies S.r.l.Industry (pharma, biotech, devices)
- Study start
- Apr 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 9 Apr 2025 (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.
The purpose of this clinical study is to evaluate the use of the TRACE4BUS software that is proposed to support the physician in reporting the results of breast ultrasound according to the international classification standard Breast Image - Reporting and Data System (BI-RADS) of the American College of Radiology. This classification is recommended because it reduces the risk of subjective interpretations of descriptive results and prevents these results from being interpreted differently by the physician who evaluated the ultrasound examination, the physician who may have requested the examination, the patient and the patient's trusted physician (family physician or specialist). The BI-RADS classification is based on the evaluation of the shape, size, margins and other characteristics of a possible breast abnormality identified on the ultrasound image by the physician who evaluated the ultrasound examination, characteristics that are not always easy for that physician to evaluate.
The study aims to verify if the BI-RADS classification by the physician can be supported by the TRACE4BUS software. In particular, it refers to the support that the software provides to the physician who has evaluated the ultrasound examination in assigning the BI-RADS category for an abnormality of the breast found to be suspicious by the physician on the basis of qualitative characteristics (shape, size, margins, preferential orientation with respect to the skin plane, internal homogeneity/inhomogeneity, possible acoustic barrier effect, etc.). The TRACE4BUS software, trained on the basis of hundreds of ultrasound images of suspicious breast masses with a certain diagnosis of benignity or malignancy at subsequent diagnostic investigations, performs a quantitative analysis of the ultrasound characteristics of a suspicious breast mass and proposes a BI-RADS category to the physician. In any case, the physician will have complete decision-making power in the final attribution of the BI-RADS category and in the subsequent recommendations or decisions regarding the medical management of the case.
The clinical study also aims to evaluate whether the agreement between physicians in the use of this BI-RADS classification of suspicious breast masses improves with the use of the software.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective cohort | – | –The investigators propose a retrospective study on patients aged ≥18 years, who have had breast masses detected on ultrasound and considered suspicious for breast cancer by physicians expert in breast ultrasound at the Breast Radiology Unit of the National Cancer Institute, Milan, Italy, from January 1, 2020 to December 31, 2021. These ultrasound images of breast masses will be those acquired in the context of ultrasound-guided core needle biopsy. |
| Prospective cohort | – | –The investigators propose a prospective design on consecutive patients (age > 18 years) with breast masses detected by ultrasound and considered suspicious for breast cancer by physicians with experience in breast ultrasound at the same clinic, from the approval data of the Ethics Committee until completion of the expected sample size. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with breast masses detected at ultrasound imaging and considered suspicious for breast cancer by physicians with experience in breast ultrasound.
Key inclusion criteria (4 listed)
- Retrospective study part:
- Prospective study part:
Key exclusion criteria (4 listed)
- Retrospective study part:
- Prospective study part:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Specificity, positive predictive value, sensitivity and negative predictive value
Time frame: From enrollment to biopsy up to 12-month follow-up when necessary
Specificity, positive predictive value, sensitivity and negative predictive value before knowing the BI-RADS category proposed by the TRACE4BUS software and after being informed of the software prediction of BI-RADS category by the TRACE4BUS software.
3 secondary outcomes
K-Cohen
Time frame: 9 months and 18 months
Number of correct answers on the use of TRACE4BUS as assessed in the training questionnaire
Time frame: From date of training in the use of TRACE4BUS software to the physicians to training efficacy questionnaire within 2 weeks
Total scores on the usability of TRACE4BUS as assessed in the usability satisfaction questionnaire
Time frame: 9 months and 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
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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.
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, run by DeepTrace Technologies S.r.l. at 1 site in Italy.
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: opening soon, as of the sponsor's last update on 9 Apr 2025. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gianfranco Scaperrotta (+39 333 257 2380, Gianfranco.Scaperrotta@istitutotumori.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Specificity, positive predictive value, sensitivity and negative predictive value (time frame: From enrollment to biopsy up to 12-month follow-up when necessary). 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 9 Apr 2025.