Effectiveness of CadAI-B Dx for Decision Support in Breast Ultrasound

BeamWorks

Status: Completed

Conditions: Breast Cancer; Breast Neoplasms

Treatments: Device: CadAI-B Dx

Study type: Interventional

Funder types: Industry

Identifiers

NCT07287111

IP0014-US-CAB-I

Details and patient eligibility

About

This is a retrospective, fully-crossed, multi-reader, multi-case (MRMC) study to evaluate the effectiveness of 'CadAI-B Dx' (CadAI-B) for decision support in breast ultrasound. The study compares the diagnostic performance of readers interpreting breast ultrasound images with and without the aid of CadAI-B. A total of 797 patient cases will be included, comprising 350 cases with a confirmed diagnosis of malignancy and 447 cases with a confirmed benign diagnosis. Sixteen readers will participate in the study to evaluate the device.

Full description

The study utilizes a crossover design where all readers independently review all cases. The control arm consists of a reading session where participating readers independently review cases without the assistance of the CadAI-B device (unaided reading). The experimental arm involves reading with CadAI-B assistance (AI-aided reading). To minimize potential bias, a washout period of four weeks will be maintained between the unassisted and assisted reading sessions for each reader. The primary hypothesis is that CadAI-B assistance significantly improves overall reader performance in breast ultrasound interpretation, as measured by the area under the Localization Receiver Operating Characteristic (LROC) curve (AULROC).

Enrollment: 797 patients

Sex: Female

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Women aged 22 years or older at the time of the breast ultrasound examination.
2. Standard B-mode breast ultrasound images available for analysis.
3. Lesions must have a confirmed diagnosis based on one of the following reference standards:

3-1. Malignant Cases: Diagnosis of breast cancer confirmed through biopsy or surgery.

3-2. Benign Cases: Confirmed as benign through biopsy or surgical excision, or confirmed as having no evidence of malignancy for at least 2 years of follow-up.

Exclusion criteria

1. mages containing modes other than standard B-mode ultrasound, such as Doppler, elastography, or other annotations/overlays.
2. Patients who have breast implant(s).
3. Patients suffering from significant breast trauma or mastitis at the time of the breast ultrasound examination.
4. Images of post-surgical resection sites.
5. Images where multiple lesions are present within a single 2D ultrasound image

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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797 participants in 2 patient groups

CadAI- Dx(AI) Unaided Reading

No Intervention group

Description:

Readers evaluate each ultrasound image without access to AI assistance. Readers use only the provided radiological images and their professional clinical expertise to determine their final diagnosis and relevant findings

CadAI-DX (AI)-aided Reading

Experimental group

Description:

Readers have access to CadAI-B's decision-support outputs, which include a pixel-level heatmap (CadAI-Map), auto-segmented lesion boundary, BI-RADS lexicon descriptors, a suggested malignancy probability score (CadAI-Score), and BI-RADS category.

Treatment:

Device: CadAI-B Dx