Artificial Intelligence in Mammography-Based Breast Cancer Screening

NCT04156880 | Withdrawn

• 1 other identifier: 2019.629
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

mammography; artificial intelligence; deep learning

Outcome Measures

Primary Outcomes (4)

• area under curve (AUC)

  area under receiver operating characteristic (ROC) curve in percentage (%)

  3 years

• accuracy

  proportion of true results(both true positives and true negatives) among whole instances

  3 years

• sensitivity

  true positive rate in percentage(%) derived by ROC analysis

  3 years

• specificity

  true negative rate in percentage (%) derived by ROC analysis

  3 years

Interventions

mammography OTHER

standard mammography including craniocaudal (CC) and mediolateral oblique (MLO) views

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This is a single institutional retrospective cohort study of patients with mammographic examinations. All patients' data will be retrieved via the electronic patient database of our institution. Patient demographics, imaging and histological data, disease and treatment history will be recorded, including age at onset, details of chemotherapy, time interval of metastasis from diagnosis, surgery for the primary tumor, the length of survival, clinical outcome and so on.

You may qualify if:

• Women who had undergone standard mammography including craniocaudal (CC) and mediolateral 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-term follow-up (\>=2 years) examinations are available for cases without breast malignancy.

You may not qualify if:

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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• IBM China/Hong Kong Limited: collaborator

Study Sites (1)

The Chinese University of Hong Kong, Prince of Wale Hospital

Hong Kong, Shatin, Hong Kong

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 6, 2019
• First Posted: November 8, 2019
• Study Start: July 1, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 7, 2024

Record last verified: 2024-02

Locations

HK (1)