Status:
NOT_YET_RECRUITING
TRACE4BUS for BI-RADS Classification
Lead Sponsor:
DeepTrace Technologies S.r.l.
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-89 years
Brief 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 internation...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
590 Patients enrolled
Trial Details
Trial ID
NCT06920108
Start Date
April 1 2025
End Date
October 1 2026
Last Update
April 9 2025
Active Locations (1)
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1
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Lombardy, Italy, 20133