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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