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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05797129
Enrollment
351
Registered
2023-04-04
Start date
2019-01-01
Completion date
2021-12-31
Last updated
2023-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

breast cancer, Contrast-enhanced digital mammography

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.

Interventions

DEVICECEDM

Women underwent CEDM screening

Sponsors

Kaohsiung Veterans General Hospital.
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 90 Years
Healthy volunteers
Yes

Inclusion criteria

* women underwent CEDM screening

Exclusion criteria

* incomplete imaging exams

Design outcomes

Primary

MeasureTime frameDescription
Total number of cases received and diagnosed with breast cancer (Number)Up to 3 yearsThis 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

MeasureTime frameDescription
Total number of cases received and diagnosed as positive requiring a biopsy and MRI (Number)Up to 3 yearsThis 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 positive results obtained by the diagnostic method (Number)Up to 3 yearsThe 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.
True negative results obtained by the diagnostic method (Number)Up to 3 yearsThe 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.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026