Breast Cancer ScreeningSINATRANCT07415499
Breast Density Impact on Mammographic Screening for Breast Cancer Diagnosis
An observational study of Breast Cancer Screening and Breast Cancer Screening and Diagnosis, run by Azienda Sanitaria Locale CN2 Alba-Bra at 1 site in Italy.
Trial summary
This retrospective, observational study aims to evaluate how breast density affects the accuracy and outcomes of mammographic screening for breast cancer within the regional screening program "Prevenzione Serena". Read more about this study
- Who is it for?
- Ages 45 to 75 years, women only
- Conditions the study is for
- Breast Cancer Screening, Breast Cancer Screening and Diagnosis
- How many people
- 3,300 participants
- Where
- 1 siteItaly
- Study dates
- 12 Jan 2026to Sep 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 45 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The study will include women aged 45 to 75 years who participated in the "Prevenzione Serena" mammography screening program and underwent screening mammography at ASL CN2 using a Siemens MAMMOMAT Revelation mammography system between September 25, 2023, and May 3, 2024.
Who may be able to join
- Women aged 45 to 75 years who participated in the "Prevenzione Serena" mammography screening program and underwent screening mammography at ASL CN2 between September 25, 2023, and May 3, 2024.
- Signed informed consent or equivalent substitute declaration, when applicable.
Who cannot join
- Women with a history of mastectomy.
- Women with breast implants.
- Women with cardiac implantable devices, such as pacemakers or loop recorders.
- Cases in which the Insight BD software cannot be applied due to compression thickness below 15 mm.
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, 1 recruiting
- Recruiting
SSD Fisica Sanitaria - Ospedale Michele e Pietro Ferrero di Verduno (CN) - ASL CN2
Verduno, Italy/CN, 12060
Francesco Lucio, Principal Investigator, +39.0172.1408486, flucio@aslcn2.it
Anna Sardo
About this study
Official title: Retrospective Study on Patients Undergoing Mammographic Screening to Evaluate the Impact of Breast Density on Breast Cancer Diagnosis
This retrospective, observational study aims to evaluate how breast density affects the accuracy and outcomes of mammographic screening for breast cancer within the regional screening program "Prevenzione Serena".
Breast density is an important factor because dense breast tissue can make it more difficult to detect breast cancer on a mammogram. Dense tissue and tumors both appear white on a mammogram, which may hide abnormalities and lead to missed cancers or false-positive results.
Read more
Women aged 45 to 75 years who underwent routine mammographic screening at ASL CN2 between September 2023 and May 2024 will be included. Breast density will be classified using the BI-RADS system (categories A-D), and the study will assess whether women with dense breasts (categories C and D) experience higher rates of recalls for second-level examinations such as ultrasound, MRI, etc).
The study also includes an internal validation of Insight BD, an automated breast-density measurement software used at ASL CN2. The software will be evaluated using a mammography phantom (to verify technical accuracy) and by comparing its BI-RADS density classifications with readings from two radiologists (one expert and one less experienced). This will help determine whether the software can support radiologists, especially in evaluating dense breast tissue.
Additional factors such as menopausal status, family history of breast cancer, and hormone therapy will also be examined to understand how they relate to breast density and screening outcomes. The study aims to quantify the frequency of false-positive recalls-cases in which additional tests are recommended but cancer is not found-because these events can increase patient anxiety and healthcare workload.
Ultimately, this research seeks to provide evidence that may inform future screening guidelines and support more personalized approaches, particularly for women with dense breasts.
Read the detailed description
This retrospective, monocentric, observational study investigates the impact of breast density on mammographic screening performance in the regional program "Prevenzione Serena," implemented at ASL CN2 (Piedmont, Italy). The primary objective is to evaluate the association between BI-RADS breast-density categories and the frequency of recalls for second-level diagnostic examinations among women aged 45-75 undergoing screening mammography between 25 September 2023 and 3 May 2024.
Breast density is a known factor that can reduce the sensitivity of mammography. Dense fibroglandular tissue appears radiopaque and may mask suspicious lesions, leading to false-negative or false-positive examinations. Women with dense breasts (BI-RADS categories C-D) also have an independently increased risk of breast cancer. For these reasons, the study aims to characterize how breast density influences recall rates, diagnostic appropriateness, and overall screening performance in a real-world population.
A secondary goal is the internal validation of Insight BD, an automated breast-density assessment software integrated into the Siemens Mammomat Revelation mammography system used at ASL CN2. The validation includes:
- Technical validation using a dedicated mammographic phantom with known density values to determine measurement accuracy and repeatability;
- Diagnostic validation through comparison between the BI-RADS density category assigned by the software and those assigned by two radiologists (one expert, one non-expert).
The study will also examine associations between breast density and key clinical factors, including menopausal status, family history of breast cancer, and systemic hormone therapy. Furthermore, the frequency of false-positive recalls (additional testing without a final diagnosis of cancer) will be assessed, given their clinical, psychological, and organizational implications.
The study aims to characterize density-related patterns in screening performance, quantify false-positive recalls, and contribute evidence to support future updates to breast-screening guidelines and potential personalized screening strategies, especially for women with dense breast tissue.
- Being tested
- No intervention is administered.
- Keywords
- Breast cancer, Breast cancer screening, BRADS, Mammography, Dense breast, Breast imaging
- Medical subject headings
- Disease, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention is administered.Other
No intervention is administered.
| Study group | Role | What they receive |
|---|---|---|
| Screening cohort | Women aged 45-75 who underwent routine mammographic screening within the "Prevenzione Serena" program at ASL CN2 between September 2023 and May 2024. Breast density (BI-RADS A-D) will be evaluated, along with recall rates, false-positive findings, and comparisons of automated breast-density assessment (Insight BD) with radiologist readings. No interventions are administered; data are collected retrospectively from clinical records. Receives: Other: No intervention is administered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recall Rate for Second-Level Examinations by BI-RADS Breast Density Category
Percentage of women recalled for second-level diagnostic examinations among all women undergoing mammographic screening, calculated separately for each BI-RADS density category (A, B, C, D) and for the dichotomized groups A-B versus C-D.
Measured: September 2023 - May 2024
Secondary outcomes (4)
Technical Performance of Insight BD: Accuracy and Repeatability on Breast Density Phantom
Evaluation of the volumetric breast density percentage produced by Insight BD on a standardized phantom, assessing measurement accuracy compared with the reference phantom values and repeatability across repeated acquisitions.
Measured: September 2023 - May 2024
Concordance Between Insight BD BI-RADS Classification and Radiologist Assessment
Diagnostic agreement between Insight BD BI-RADS breast density classification and radiologist assessments. The outcome includes:
- Percent agreement with the expert radiologist (primary reference).
- Percent agreement with a non-expert radiologist to evaluate the tool's impact on less-experienced readers.
Measured: September 2023 - May 2024
Recall Rate for Second-Level Examinations in Negative Mammographic Screens by BI-RADS Density
Proportion of women recalled for second-level diagnostic examinations among those with a negative screening mammogram, stratified by BI-RADS breast density categories (A, B, C, D) and by dichotomized density groups (A-B vs C-D).
Measured: September 2023 - May 2024
Distribution of Breast Density by Menopausal Status, Hormonal Therapy, and Family History
Proportion of participants in each BI-RADS breast density category (A, B, C, D), and in dichotomized density groups (A-B vs C-D), stratified by:
menopausal status (pre/post-menopause), use of hormonal therapy (yes/no), family history of breast cancer (yes/no).
Measured: September 2023 - May 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start12 Jan 2026
- Primary completionJun 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer ScreeningStudies 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
- Retrospective
- Enrolment
- 3,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria Locale CN2 Alba-Bra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07415499
- Sponsor's protocol ID
- SINATRA
- Acronym
- SINATRA
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ray KM, Price ER, Joe BN. Breast density legislation: mandatory disclosure to patients, alternative screening, billing, reimbursement. AJR Am J Roentgenol. 2015 Feb;204(2):257-60. doi: 10.2214/AJR.14.13558.
PubMed 25615746Dehkordy SF, Carlos RC. Dense Breast Legislation in the United States: State of the States. J Am Coll Radiol. 2016 Nov;13(11S):R53-R57. doi: 10.1016/j.jacr.2016.09.027.
PubMed 27814815Damases CN, Brennan PC, Mello-Thoms C, McEntee MF. Mammographic Breast Density Assessment Using Automated Volumetric Software and Breast Imaging Reporting and Data System (BIRADS) Categorization by Expert Radiologists. Acad Radiol. 2016 Jan;23(1):70-7. doi: 10.1016/j.acra.2015.09.011. Epub 2015 Oct 26.
PubMed 26514436Pesce K, Tajerian M, Chico MJ, Swiecicki MP, Boietti B, Frangella MJ, Benitez S. Interobserver and intraobserver variability in determining breast density according to the fifth edition of the BI-RADS(R) Atlas. Radiologia (Engl Ed). 2020 Nov-Dec;62(6):481-486. doi: 10.1016/j.rx.2020.04.006. Epub 2020 May 31. English, Spanish.
PubMed 32493654Sheehan J. Brain fragments: Leksell's autobiography newly translated to English. J Neurooncol. 2022 Apr;157(2):383. doi: 10.1007/s11060-022-03968-y. Epub 2022 Mar 29. No abstract available.
PubMed 35348987Martinez-Navarro B, Sanchis R, Asedegbega-Nieto E, Solsona B, Ivars-Barcelo F. (Ag)Pd-Fe3O4 Nanocomposites as Novel Catalysts for Methane Partial Oxidation at Low Temperature. Nanomaterials (Basel). 2020 May 21;10(5):988. doi: 10.3390/nano10050988.
PubMed 32455643Zimri K, Hesseling AC, Godfrey-Faussett P, Schaaf HS, Seddon JA. Why do child contacts of multidrug-resistant tuberculosis not come to the assessment clinic? Public Health Action. 2012 Sep 21;2(3):71-5. doi: 10.5588/pha.12.0024.
PubMed 26392955Oliver A, Tortajada M, Llado X, Freixenet J, Ganau S, Tortajada L, Vilagran M, Sentis M, Marti R. Breast Density Analysis Using an Automatic Density Segmentation Algorithm. J Digit Imaging. 2015 Oct;28(5):604-12. doi: 10.1007/s10278-015-9777-5.
PubMed 25720749Eng A, Gallant Z, Shepherd J, McCormack V, Li J, Dowsett M, Vinnicombe S, Allen S, dos-Santos-Silva I. Digital mammographic density and breast cancer risk: a case-control study of six alternative density assessment methods. Breast Cancer Res. 2014 Sep 20;16(5):439. doi: 10.1186/s13058-014-0439-1.
PubMed 25239205Sartor H, Lang K, Rosso A, Borgquist S, Zackrisson S, Timberg P. Measuring mammographic density: comparing a fully automated volumetric assessment versus European radiologists' qualitative classification. Eur Radiol. 2016 Dec;26(12):4354-4360. doi: 10.1007/s00330-016-4309-3. Epub 2016 Mar 24.
PubMed 27011371Jeffers AM, Sieh W, Lipson JA, Rothstein JH, McGuire V, Whittemore AS, Rubin DL. Breast Cancer Risk and Mammographic Density Assessed with Semiautomated and Fully Automated Methods and BI-RADS. Radiology. 2017 Feb;282(2):348-355. doi: 10.1148/radiol.2016152062. Epub 2016 Sep 5.
PubMed 27598536
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study on Patients Undergoing Mammographic Screening to Evaluate the Impact of Breast Density on Breast Cancer Diagnosis
- ClinicalTrials.gov ID
- NCT07415499
- Acronym / sponsor ID
- SINATRA / SINATRA
- Keywords
- Breast cancer, Breast cancer screening, BRADS, Mammography, Dense breast, Breast imaging
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,300 participants (estimated)
- Lead sponsor
- Azienda Sanitaria Locale CN2 Alba-BraUniversity, hospital or other
- Study start
- 12 Jan 2026 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 17 Feb 2026 (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.
This retrospective, observational study aims to evaluate how breast density affects the accuracy and outcomes of mammographic screening for breast cancer within the regional screening program "Prevenzione Serena".
Breast density is an important factor because dense breast tissue can make it more difficult to detect breast cancer on a mammogram. Dense tissue and tumors both appear white on a mammogram, which may hide abnormalities and lead to missed cancers or false-positive results.
Women aged 45 to 75 years who underwent routine mammographic screening at ASL CN2 between September 2023 and May 2024 will be included. Breast density will be classified using the BI-RADS system (categories A-D), and the study will assess whether women with dense breasts (categories C and D) experience higher rates of recalls for second-level examinations such as ultrasound, MRI, etc).
The study also includes an internal validation of Insight BD, an automated breast-density measurement software used at ASL CN2. The software will be evaluated using a mammography phantom (to verify technical accuracy) and by comparing its BI-RADS density classifications with readings from two radiologists (one expert and one less experienced). This will help determine whether the software can support radiologists, especially in evaluating dense breast tissue.
Additional factors such as menopausal status, family history of breast cancer, and hormone therapy will also be examined to understand how they relate to breast density and screening outcomes. The study aims to quantify the frequency of false-positive recalls-cases in which additional tests are recommended but cancer is not found-because these events can increase patient anxiety and healthcare workload.
Ultimately, this research seeks to provide evidence that may inform future screening guidelines and support more personalized approaches, particularly for women with dense breasts.
Detailed description
This retrospective, monocentric, observational study investigates the impact of breast density on mammographic screening performance in the regional program "Prevenzione Serena," implemented at ASL CN2 (Piedmont, Italy). The primary objective is to evaluate the association between BI-RADS breast-density categories and the frequency of recalls for second-level diagnostic examinations among women aged 45-75 undergoing screening mammography between 25 September 2023 and 3 May 2024.
Breast density is a known factor that can reduce the sensitivity of mammography. Dense fibroglandular tissue appears radiopaque and may mask suspicious lesions, leading to false-negative or false-positive examinations. Women with dense breasts (BI-RADS categories C-D) also have an independently increased risk of breast cancer. For these reasons, the study aims to characterize how breast density influences recall rates, diagnostic appropriateness, and overall screening performance in a real-world population.
A secondary goal is the internal validation of Insight BD, an automated breast-density assessment software integrated into the Siemens Mammomat Revelation mammography system used at ASL CN2. The validation includes:
- Technical validation using a dedicated mammographic phantom with known density values to determine measurement accuracy and repeatability;
- Diagnostic validation through comparison between the BI-RADS density category assigned by the software and those assigned by two radiologists (one expert, one non-expert).
The study will also examine associations between breast density and key clinical factors, including menopausal status, family history of breast cancer, and systemic hormone therapy. Furthermore, the frequency of false-positive recalls (additional testing without a final diagnosis of cancer) will be assessed, given their clinical, psychological, and organizational implications.
The study aims to characterize density-related patterns in screening performance, quantify false-positive recalls, and contribute evidence to support future updates to breast-screening guidelines and potential personalized screening strategies, especially for women with dense breast tissue.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening cohort | – | Other: No intervention is administered.Women aged 45-75 who underwent routine mammographic screening within the "Prevenzione Serena" program at ASL CN2 between September 2023 and May 2024. Breast density (BI-RADS A-D) will be evaluated, along with recall rates, false-positive findings, and comparisons of automated breast-density assessment (Insight BD) with radiologist readings. No interventions are administered; data are collected retrospectively from clinical records. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include women aged 45 to 75 years who participated in the "Prevenzione Serena" mammography screening program and underwent screening mammography at ASL CN2 using a Siemens MAMMOMAT Revelation mammography system between September 25, 2023, and May 3, 2024.
Key inclusion criteria (2 listed)
- Women aged 45 to 75 years who participated in the "Prevenzione Serena" mammography screening program and underwent screening mammography at ASL CN2 between September 25, 2023, and May 3, 2024.
- Signed informed consent or equivalent substitute declaration, when applicable.
Key exclusion criteria (4 listed)
- Women with a history of mastectomy.
- Women with breast implants.
- Women with cardiac implantable devices, such as pacemakers or loop recorders.
- Cases in which the Insight BD software cannot be applied due to compression thickness below 15 mm.
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 |
|---|---|---|
| No intervention is administered.No intervention is administered. | Other | Screening cohort |
Primary outcome
Recall Rate for Second-Level Examinations by BI-RADS Breast Density Category
Time frame: September 2023 - May 2024
Percentage of women recalled for second-level diagnostic examinations among all women undergoing mammographic screening, calculated separately for each BI-RADS density category (A, B, C, D) and for the dichotomized groups A-B versus C-D.
4 secondary outcomes
Technical Performance of Insight BD: Accuracy and Repeatability on Breast Density Phantom
Time frame: September 2023 - May 2024
Concordance Between Insight BD BI-RADS Classification and Radiologist Assessment
Time frame: September 2023 - May 2024
Recall Rate for Second-Level Examinations in Negative Mammographic Screens by BI-RADS Density
Time frame: September 2023 - May 2024
Distribution of Breast Density by Menopausal Status, Hormonal Therapy, and Family History
Time frame: September 2023 - May 2024
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 17 Feb 2026.
- Background: PubMed 25615746Ray KM, Price ER, Joe BN. Breast density legislation: mandatory disclosure to patients, alternative screening, billing, reimbursement. AJR Am J Roentgenol. 2015 Feb;204(2):257-60. doi: 10.2214/AJR.14.13558.
- Background: PubMed 27814815Dehkordy SF, Carlos RC. Dense Breast Legislation in the United States: State of the States. J Am Coll Radiol. 2016 Nov;13(11S):R53-R57. doi: 10.1016/j.jacr.2016.09.027.
- Background: PubMed 26514436Damases CN, Brennan PC, Mello-Thoms C, McEntee MF. Mammographic Breast Density Assessment Using Automated Volumetric Software and Breast Imaging Reporting and Data System (BIRADS) Categorization by Expert Radiologists. Acad Radiol. 2016 Jan;23(1):70-7. doi: 10.1016/j.acra.2015.09.011. Epub 2015 Oct 26.
- Background: PubMed 32493654Pesce K, Tajerian M, Chico MJ, Swiecicki MP, Boietti B, Frangella MJ, Benitez S. Interobserver and intraobserver variability in determining breast density according to the fifth edition of the BI-RADS(R) Atlas. Radiologia (Engl Ed). 2020 Nov-Dec;62(6):481-486. doi: 10.1016/j.rx.2020.04.006. Epub 2020 May 31. English, Spanish.
- Background: PubMed 35348987Sheehan J. Brain fragments: Leksell's autobiography newly translated to English. J Neurooncol. 2022 Apr;157(2):383. doi: 10.1007/s11060-022-03968-y. Epub 2022 Mar 29. No abstract available.
- Background: PubMed 32455643Martinez-Navarro B, Sanchis R, Asedegbega-Nieto E, Solsona B, Ivars-Barcelo F. (Ag)Pd-Fe3O4 Nanocomposites as Novel Catalysts for Methane Partial Oxidation at Low Temperature. Nanomaterials (Basel). 2020 May 21;10(5):988. doi: 10.3390/nano10050988.
- Background: PubMed 26392955Zimri K, Hesseling AC, Godfrey-Faussett P, Schaaf HS, Seddon JA. Why do child contacts of multidrug-resistant tuberculosis not come to the assessment clinic? Public Health Action. 2012 Sep 21;2(3):71-5. doi: 10.5588/pha.12.0024.
- Background: PubMed 25720749Oliver A, Tortajada M, Llado X, Freixenet J, Ganau S, Tortajada L, Vilagran M, Sentis M, Marti R. Breast Density Analysis Using an Automatic Density Segmentation Algorithm. J Digit Imaging. 2015 Oct;28(5):604-12. doi: 10.1007/s10278-015-9777-5.
- Background: PubMed 25239205Eng A, Gallant Z, Shepherd J, McCormack V, Li J, Dowsett M, Vinnicombe S, Allen S, dos-Santos-Silva I. Digital mammographic density and breast cancer risk: a case-control study of six alternative density assessment methods. Breast Cancer Res. 2014 Sep 20;16(5):439. doi: 10.1186/s13058-014-0439-1.
- Background: PubMed 27011371Sartor H, Lang K, Rosso A, Borgquist S, Zackrisson S, Timberg P. Measuring mammographic density: comparing a fully automated volumetric assessment versus European radiologists' qualitative classification. Eur Radiol. 2016 Dec;26(12):4354-4360. doi: 10.1007/s00330-016-4309-3. Epub 2016 Mar 24.
- Background: PubMed 27598536Jeffers AM, Sieh W, Lipson JA, Rothstein JH, McGuire V, Whittemore AS, Rubin DL. Breast Cancer Risk and Mammographic Density Assessed with Semiautomated and Fully Automated Methods and BI-RADS. Radiology. 2017 Feb;282(2):348-355. doi: 10.1148/radiol.2016152062. Epub 2016 Sep 5.
- Individual participant dataSharing planned: Undecided
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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 Screening and Breast Cancer Screening and Diagnosis, run by Azienda Sanitaria Locale CN2 Alba-Bra 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 2 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: looking for participants now, as of the sponsor's last update on 17 Feb 2026. 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 Francesco Lucio, Principal Investigator (+39.0172.1408486, flucio@aslcn2.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recall Rate for Second-Level Examinations by BI-RADS Breast Density Category (time frame: September 2023 - May 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07415499, which also lists 11 linked publications.
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 17 Feb 2026.