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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05797129
• Other study ID #: VGHKS18-CT11-17
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2023
• Source: Kaohsiung Veterans General Hospital.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 351
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 90 Years

Eligibility

Inclusion Criteria:

• women underwent CEDM screening

Exclusion Criteria:

• incomplete imaging exams

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• CEDM
Women underwent CEDM screening

Locations

Country	Name	City	State
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Veterans General Hospital.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total number of cases received and diagnosed with breast cancer (Number)	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.	Up to 3 years
Secondary	Total number of cases received and diagnosed as positive requiring a biopsy and MRI (Number)	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.	Up to 3 years
Secondary	True positive results obtained by the diagnostic method (Number)	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.	Up to 3 years
Secondary	True negative results obtained by the diagnostic method (Number)	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.	Up to 3 years