Artificial Intelligence for Automated Diagnosis of Breast Cancer

NCT ID: NCT05858762

Last Updated: 2023-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-20

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer Diagnosis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Breast digital tomosynthesis

Introduction of an almost three-dimensional imaging technique called breast digital tomosynthesis

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Regina Elena Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Università degli Studi di Napoli Federico II

Napoli, , Italy

Site Status RECRUITING

"Regina Elena" National Cancer Institute

Rome, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Valeria Landoni

Role: CONTACT

+39 06 52665602

Facility Contacts

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Giovanni Mettivier

Role: primary

Other Identifiers

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RS1414/20

Identifier Type: -

Identifier Source: org_study_id

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