Effectiveness of CadAI-B for Breast
Multi-Reader Multi-Case, retrospektiv undersøgelse for at evaluere effektiviteten af CadAI-B til bryst
The purpose of this study is to evaluate the effectiveness of lesion detection and diagnosis-aiding software (CadAI-B for Breast) during ultrasound (US) examination
Studieoversigt
Detaljeret beskrivelse
CadAI-B for Breast is a real-time artificial intelligence (AI) diagnosis system designed to assist healthcare professionals in lesion detection and differential diagnosis during breast US examinations. The primary objective of the study is to evaluate the effectiveness of CadAI-B in the assistance of detection and diagnosis of breast cancer by comparing the clinical performance of physicians before and after using CadAI-B in their ultrasound reading. The secondary objective of this study is to evaluate the sensitivity and specificity using CadAI-B for US examinations.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
-
Seoul, Sydkorea, 03722
- Yonsei University Severance Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Mainly recruited from a tertiary hospital but no limitation of enrollment
Beskrivelse
Inclusion Criteria:
- Women who underwent breast US examination
- Women with breast cancer (DCIS or invasive cancer) diagnosed via biopsy
- Women who had been followed for more than 2 years after initial US examination
Exclusion Criteria:
- women who had breast implants
- women who had US images containing artifacts affecting the review of images
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: RETROSPECTIVE
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Cancer group
confirmed as a breast cancer (ductal carcinoma in situ (DCIS) or invasive cancer) through the subsequent biopsy conducted within following 1 year of the ultrasound exam. |
CadAI-B for Breast is designed to assist healthcare professionals in lesion detection and differential diagnosis during breast US examinations. |
|
Benign group
Either confirmed as a benign through the subsequent biopsy conducted within following 1 year of the ultrasound exam or showing stability on more than 2 years of imaging follow-up after initial diagnosis |
CadAI-B for Breast is designed to assist healthcare professionals in lesion detection and differential diagnosis during breast US examinations. |
|
Normal group
Interpreted as Breast Imaging Reporting and Data System (BI-RADS) category 1 (Negative) with no cancers on the ultrasound exam |
CadAI-B for Breast is designed to assist healthcare professionals in lesion detection and differential diagnosis during breast US examinations. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Area Under the LROC Curve
Tidsramme: 6 weeks
|
Area Under the Localization Receiver Operating Characteristic (LROC) Curve |
6 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Lesion detection sensitivity and specificity
Tidsramme: 6 weeks
|
The mean sensitivity and specificity of 15 readers were calculated and compared between the aided and unaided sessions. |
6 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- DP0001-SEV-CAB-II
- RS-2023-00227526 (Andet bevillings-/finansieringsnummer: Korea Ministry of Science and ICT)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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