CEDM as a Screening Tool for Breast Cancer in Higher-risk Women: A Prospective Study

Completed

• Conditions: Breast Cancer

• Registration Number: NCT05797129
• Lead Sponsor: Kaohsiung Veterans General Hospital.

Brief Summary

To evaluate the effectiveness of Contrast-enhanced digital mammography (CEDM) in detecting breast cancer in women at higher risk.

Detailed Description

The aim of this study was to evaluate the effectiveness of different imaging techniques for detecting breast cancer in women with a higher risk due to personal or family history of the disease.

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2023-03
• Study First Submitted: 2023-03-08
• Study First Submitted QC: 2023-03-21
• Last Update Submitted: 2023-03-21
• Study First Posted: 2023-04-04
• Last Update Posted: 2023-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 351

Inclusion Criteria

• women underwent CEDM screening

Exclusion Criteria

• incomplete imaging exams

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total number of cases received and diagnosed with breast cancer (Number)	Up to 3 years	This refers to the total number of individuals who underwent breast cancer screening or assessment and the number diagnosed with breast cancer. Evaluating the accuracy of screening tests using measures such as true positives and true negatives is crucial for assessing the reliability of screening tests and identifying potential issues. These measures help healthcare professionals make informed decisions about screening and diagnostic strategies.

Secondary Outcome Measures

Name	Time	Method
True positive results obtained by the diagnostic method (Number)	Up to 3 years	The total number of true positive results obtained by the diagnostic method, indicating the cases with breast cancer that are correctly identified. A higher number of true positives demonstrates better performance in correctly identifying cases with breast cancer.
Total number of cases received and diagnosed as positive requiring a biopsy and MRI (Number)	Up to 3 years	This refers to the total number of individuals who underwent breast cancer screening or assessment and tested positive, requiring a biopsy and MRI for further evaluation. A biopsy is necessary to confirm whether an individual has breast cancer. Monitoring the diagnostic accuracy of breast cancer screening tests and the number of individuals requiring further procedures is essential for determining appropriate treatment or monitoring. Measures such as true positives and true negatives are used to evaluate the accuracy of screening tests.
True negative results obtained by the diagnostic method (Number)	Up to 3 years	The total number of true negative results obtained by the diagnostic method, indicating the cases without breast cancer that are correctly identified. A higher number of true negatives demonstrates better performance in correctly identifying cases without breast cancer and reducing false positives.

Trial Locations

Locations (1)

Kaohsiung Veterans General Hospital; 🇨🇳 Kaohsiung, Taiwan