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Trial Title: Artificial Intelligence for Automated Diagnosis of Breast Cancer

NCT ID: NCT05858762

Condition: Breast Cancer Diagnosis

Conditions: Official terms:
Breast Neoplasms
Disease

Study type: Observational [Patient Registry]

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Diagnostic Test
Intervention name: Breast digital tomosynthesis
Description: Introduction of an almost three-dimensional imaging technique called breast digital tomosynthesis

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.

Criteria for eligibility:

Study pop:
Women undergoing mammography

Sampling method: Non-Probability Sample
Criteria:
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

Gender: Female

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Università degli Studi di Napoli Federico II

Address:
City: Napoli
Zip: 80138
Country: Italy

Status: Recruiting

Contact:
Last name: Giovanni Mettivier

Facility:
Name: "Regina Elena" National Cancer Institute

Address:
City: Rome
Zip: 00144
Country: Italy

Status: Recruiting

Start date: October 20, 2020

Completion date: December 31, 2023

Lead sponsor:
Agency: Regina Elena Cancer Institute
Agency class: Other

Source: Regina Elena Cancer Institute

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05858762

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