Clinical trial · Observational
CEDM as a Screening Tool for Breast Cancer in Higher-risk Women: A Prospective Study
NCT05797129CI-TRIAL-00065299completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the effectiveness of Contrast-enhanced digital mammography (CEDM) in detecting breast cancer in women at higher risk.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CEDM | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Total number of cases received and diagnosed with breast cancer (Number)
- timeFrame
- Up to 3 years
- description
- 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 outcomes (3)
- measure
- Total number of cases received and diagnosed as positive requiring a biopsy and MRI (Number)
- timeFrame
- Up to 3 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * women underwent CEDM screening Exclusion Criteria: * incomplete imaging exams
References
Publications (0)
Data not yet available
No reference posted for this study.