Artificial Intelligence for Automated Diagnosis of Breast Cancer

Breast Cancer Diagnosis Clinical Trial

— AICAMAMMELLA  

Official title:

Study of an Artificial Intelligence Algorithm for the Classification of Digital Tomosynthesis Breast Images for Automated Breast Cancer Diagnosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05858762
• Other study ID #: RS1414/20
• Status: Recruiting
• Start date: October 20, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: Regina Elena Cancer Institute
• Contact: Valeria Landoni
• Phone: +39 06 52665602
• Email: valeria.landoni[@]ifo.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Mammography is a two-dimensional imaging technique which involves the tissues overlapping under the projective image; dense glandular tissue above or below the lesion can reduce the visibility of the lesion. The trouble could be the interpretation of the image obtained which may lead to the inability to visualize a fist stage cancer and the probability that to a healthy person will be diagnosed a pathology that is not present (false positive). The introduction of an almost three-dimensional technique imaging called breast digital tomosynthesis (DBT) can overcome most limitations. In the last 5 years image analysis methods based on Artificial Intelligence (, AI) have also been massively introduced in breast cancer detection. The study is a prospective observational study based on Artificial intelligence whose the mail goal is to develop a method to identify a lesion.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2023
• Est. primary completion date: November 25, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who refer to the Regina Elena for diagnostic mammography tests
• Informed consent

Exclusion Criteria:

• presence of prostheses, artifacts, outcomes of a study in the breast intervention under the study

Related Conditions & MeSH terms

• Breast Cancer Diagnosis
• Breast Neoplasms
• Disease

Intervention

Diagnostic Test:
• Breast digital tomosynthesis
Introduction of an almost three-dimensional imaging technique called breast digital tomosynthesis

Locations

Country	Name	City	State
Italy	Università degli Studi di Napoli Federico II	Napoli
Italy	"Regina Elena" National Cancer Institute	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Regina Elena Cancer Institute

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Artificial Intelligence system to detect a lesion	Lesion detction is based on breast density, case type, BIRADS assessment categories, mammographic appearance, size and pathological profile of malignant lesions	12 months