Artificial Intelligence in Mammography-Based Breast Cancer Screening

Last updated: February 5, 2024
Sponsor: Chinese University of Hong Kong
Overall Status: Trial Not Available

Phase

N/A

Condition

Breast Cancer

Cancer

Treatment

mammography

Clinical Study ID

NCT04156880
2019.629
  • Female
  • Accepts Healthy Volunteers

Study Summary

Breast cancer (BC) is the most common cancer among women in worldwide and the second leading cause of cancer-related death.

As the corner stone of BC screening, mammography is recognized as one of useful imaging modalities to reduce BC mortality, by virtue of early detection of BC. However, mammography interpretation is inherently subjective assessment, and prone to overdiagnosis.

In recent years, artificial intelligence (AI)-Computer Aided Diagnosis (CAD) systems, characterized by embedded deep-learning algorithms, have entered into the field of BC screening as an aid for radiologist, with purpose to optimize conventional CAD system with weakness of hand-crafted features extraction. For now, stand-alone performance of novel AI-CAD tools have demonstrated promising accuracy and efficiency in BC diagnosis, largely attributed to utilization of convolution neural network(CNNs), and some of them have already achieved radiologist-like level. On the other hand, radiologists' performance on BC screening has shown to be enhanced, by leveraging AI-CAD system as decision support tool. As increasing implementation of commercial AI-CAD system, robust evaluation of its usefulness and cost-effectiveness in clinical circumstances should be undertaken in scenarios mimicking real life before broad adoption, like other emerging and promising technologies. This requires to validate AI-CAD systems in BC screening on multiple, diverse and representative datasets and also to estimate the interface between reader and system. This proposed study seeks to investigate the breast cancer diagnostic performance of AI-CAD system used for reading mammograms. In this work, we will employ a commercially available AI-CAD tool based on deep-learning algorithms (IBM Watson Imaging AI Solution) to identify and characterize the suspicious breast lesions on mammograms. The potential cancer lesions can be labeled and their mammographic features and malignancy probability will be automatically reported. After AI post-processing, we shall further carry out statistical analysis to determine the accuracy of AI-CAD system for BC risk prediction.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Women who had undergone standard mammography including craniocaudal (CC) andmediolateral oblique (MLO) views..
  • Histopathology-proven diagnosis is available for patients with breast malignancy,including invasive breast cancer, carcinoma in situ, and borderline lesion et al.
  • As reference standard of benign nature, results from pathology or clinical long-termfollow-up (>=2 years) examinations are available for cases without breast malignancy.

Exclusion

Exclusion Criteria:

  • Patients with concurring lesions on mammograms that may influence subsequent AIpost-process.
  • Patients without available pathologic diagnosis or long-term follow-up (>=2 years)examinations.
  • Patients who had undergone breast surgical intervention (e.g. lumpectomy andmammoplasty) prior to first mammography.
  • Patients diagnosed with other kinds of malignancy, concurrent with metastasis orinfiltration/invasion to breast.

Study Design

Treatment Group(s): 1
Primary Treatment: mammography
Phase:
Study Start date:
July 01, 2020
Estimated Completion Date:
December 31, 2023

Connect with a study center

  • The Chinese University of Hong Kong, Prince of Wale Hospital

    Hong Kong, Shatin
    Hong Kong

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.