Clinical trial · Observational
DWI Breast MRI in Dense Breast: A Clinical Trial to Assess the Efficacy and Diagnostic Accuracy of Diffusion Weighted Imaging in Dense Breast Tissue
- 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)
his clinical trial aims to evaluate the efficacy and diagnostic accuracy of Diffusion Weighted Imaging (DWI) in breast MRI for women with dense breast tissue. DWI is investigated as an adjunctive method to improve early tumor detection in women with dense breasts, a group at high risk for delayed diagnosis due to limited visibility in mammography. Study Purpose: To assess the utility of Diffusion Weighted Imaging (DWI) in improving diagnostic accuracy for patients with dense breasts.
Conditions
Conditions (3)
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 Detection | — | UNRESOLVED | — |
| Dense Breast Parenchyma | — | UNRESOLVED | — |
| DWI | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Group of women with dense breast
Primary outcomes (1)
- measure
- Accuracy of Diffusion Weighted Imaging (DWI) in Dense Breast Tissue: A Retrospective Cohort Study
- timeFrame
- 12 months
- description
- This retrospective cohort study aims to assess the diagnostic accuracy and clinical utility of Diffusion Weighted Imaging (DWI) in breast MRI for women with dense breast tissue. By analyzing previously collected imaging data, the study evaluates the sensitivity, specificity, and predictive value of DWI in detecting malignant breast lesions. The research also examines the correlation between Apparent Diffusion Coefficient (ADC) values and histopathological tumor characteristics, comparing DWI's performance with conventional MRI and mammography/tomosynthesis.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Women aged 40-75 years. * Patients with dense breast tissue, classified according to BI-RADS (Breast Imaging-Reporting and Data System). * Patients who previously underwent breast MRI, including Diffusion Weighted Imaging (DWI). * Availability of histopathological confirmation for breast lesions (biopsy results). Exclusion Criteria: * Patients with a known allergy to gadolinium-based contrast agents. * Pregnant or breastfeeding women at the time of imaging. * Presence of metallic implants or other MRI-incompatible devices. * Patients with incomplete imaging datasets (e.g., missing DWI sequences or non-standardized protocols). * Prior history of breast cancer treatment (surgery, chemotherapy, or radiotherapy) before the imaging study.
References
Publications (0)
Data not yet available