Clinical trial NCT06428799: Evaluation of Carebot AI MMG Medical Device for Breast Lesion Detection and Density Assessment
Official title: Evaluation of Carebot AI MMG Medical Device for Detection and Radiographic Assessment of Breast Lesions and Quantitative Analysis of Breast Density: A Multicentric, Multi-Reader Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Breast Tumor Benign
Lead sponsor: Carebot s.r.o.
Sponsor class: INDUSTRY
First posted: 2024-05-24
Enrollment: 122
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 122 mammography studies (488 images, the so-called "test data") were obtained from the reference sites for the evaluation by radiologists and the Carebot AI MMG v2.2. The target sites used different mammography X-ray machines: Site 1 and Site 2 used the Senographe Essential mammography machine from GE HealthCare to image patients, and Site 3 used the Selenia Dimensions mammography machine from Hologic and the MAMMOMAT Revelation mammography machine from Siemens Healthineers.

Brief summary: Comparison of accuracy of clinician and DLAD image evaluation (Carebot AI MMG v2.2)

1. Comparison of the Accuracy of Density Assessment by Clinician and DLAD (DENS)
2. Comparison of Accuracy of Lesion Assessment by Clinician and DLAD (MASS, CLASS)

Detailed description: The mammography studies were acquired from three independent sites: Site 1 (EUC Mamocentrum Brno) and Site 2 (Hospital Šumperk, a.s.) specialise in routine screening mammography, and Site 3 (Masaryk Memorial Cancer Institute) is a comprehensive oncology facility primarily dedicated to diagnostic mammography, i.e. performing additional examinations in case of a suspicious finding (recall).

The ground truth was obtained by consensus of two board-certified radiologists with expertise in radiology and diagnostic methods, and 13 and 27 years of experience with mammography image interpretation, respectively.

For comparative analysis, a team of five independent radiologists with clinical experience in interpreting mammography images was established. Three of the clinicians were junior (2, 2, and 4 years of experience, respectively) without board-certification; two physicians were senior (7 and 8 years of experience, respectively), board-certified.

Eligibility criteria: Inclusion Criteria:

* The medical device is intended for use in women over 18 years of age who are indicated for screening mammography using digital mammography.

Exclusion Criteria:

* The medical device cannot be used in patients with breast implants.
* The medical device cannot be used in male breast examination.
* The medical device cannot be used in patients under 18 years of age.

Primary outcomes:
measure: Performance Test
timeFrame: 2024
Secondary outcomes:
measure: Comparison of Accuracy of Clinician and DLAD Image Evaluation (Carebot AI MMG v2.2) in Breast Density Assessment
timeFrame: 2024
measure: Comparison of Accuracy of Clinician and DLAD Image Evaluation (Carebot AI MMG v2.2) in Breast Lesion Detection
timeFrame: 2024
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: EUC Mamocentrum Brno
city: Brno
country: Czechia
facility: Masaryk Memorial Cancer Institute
city: Šumperk
country: Czechia
facility: Hospital Šumperk
Study officials:
References: