AICAMAMMELLA: Artificial Intelligence for Automated Diagnosis of Breast Cancer

• Sponsor: Regina Elena Cancer Institute (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05858762
• Collaborator: (none)
• Enrollment: 200
• Locations: 2
• Anticipated Duration (Months): 38.3
• Patients Per Site: 100
• Patients Per Site Per Month: 2.6

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Diagnosis	Diagnostic Test: Breast digital tomosynthesis

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 200 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Study of an Artificial Intelligence Algorithm for the Classification of Digital Tomosynthesis Breast Images for Automated Breast Cancer Diagnosis
• Actual Study Start Date: Oct 20, 2020
• Actual Primary Completion Date: Nov 25, 2022
• Anticipated Study Completion Date: Dec 31, 2023

Outcome Measures

Primary Outcome Measures

1. Artificial Intelligence system to detect a lesion [12 months]

   Lesion detction is based on breast density, case type, BIRADS assessment categories, mammographic appearance, size and pathological profile of malignant lesions

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Università degli Studi di Napoli Federico II	Napoli		Italy	80138
2	"Regina Elena" National Cancer Institute	Rome		Italy	00144

Sponsors and Collaborators

• Regina Elena Cancer Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Regina Elena Cancer Institute
• ClinicalTrials.gov Identifier: NCT05858762
• Other Study ID Numbers: RS1414/20
• First Posted: May 15, 2023
• Last Update Posted: May 15, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Breast Neoplasms; Disease

Study Results

No Results Posted as of May 15, 2023