Clinical trial · Observational
Digital Breast Tomosynthesis Versus Contrast Enhanced Magnetic Resonance Imaging (MRI) for Breast Cancer Staging
A Comparison of the Diagnostic Accuracy of Adjunctive Digital Breast Tomosynthesis Versus Adjunctive Contrast Enhanced Breast Magnetic Resonance Imaging in the Preoperative Assessment of Breast Cancer
- 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)
The primary objective of this study is to compare the diagnostic accuracy of Digital Breast Tomosynthesis (DBT) versus that of Contrast Enhanced Magnetic Resonance Imaging (CEMRI) in determining the size of breast cancer preoperatively. Secondary objectives include: 1. Comparing the operating characteristics of each combined imaging protocol with respect to the reference standard, i.e. histopathologic assessment, of additional non-index lesions. 2. Comparison of re-excision rates based on estimated disease extent from adjunctive CEMRI vs. adjunctive DBT. 3. Evaluation of patient satisfaction with regard to the adjunctive modality (DBT vs. CEMRI).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ductal Carcinoma In Situ | Breast Ductal Carcinoma In Situ | ALIAS | 0.90 |
| Invasive Breast Cancer | Invasive Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Breast Cancer
- description
- Women shown to have DCIS or invasive breast cancer by fine needle aspiration cytology and/or core needle biopsy.
Primary outcomes (1)
- measure
- Comparison between the accuracy of DBT vs. CEMRI using two measurements: 1. Maximal diameter estimate by imaging modality and 2. Maximal diameter based on histopathology gold standard.
- timeFrame
- surgical pathology results completed
Secondary outcomes (3)
- measure
- True positives, true negatives, false positives and false negatives for: 1. Multi-focality defined as additional discrete discontinuous tumor foci that are at least 2.5 cm separate from the index lesion. 2. Contralateral disease: presence/absence
- timeFrame
- surgical pathology results completed
- measure
- Predicted re-excision rates based on size estimates from each imaging paradigm
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
Show eligibility criteria text
Inclusion Criteria: * Subject is female of any race and ethnicity * Subject is at least 30 years old * Subject has histologically proven DCIS or invasive breast carcinoma. * Subject is able to undergo CEMRI at DHMC-Lebanon Exclusion Criteria: * Patients who are pregnant or think they may be pregnant * Patients who are breast-feeding. * Patients who have significant existing breast trauma * Subjects unable or unwilling to undergo informed consent * Absolute contraindication to CEMRI, including: 1. presence of implanted electrical device (pacemaker or neurostimulator),aneurysm clip, or metallic foreign body in or near the eyes 2. life threatening allergy to gadolinium contrast * CEMRI performed at institution other than DHMC Lebanon * Patients undergoing neoadjuvant therapy * Patients with maximum tumor diameter \>5cm * Patients presenting with Inflammatory Breast Cancer * Patients with gross axillary lymphadenopathy on clinical exam or by imaging * Maximum breast size limitation: i.e. breast size that exceeds the size of the large format image receptor (24cm x 29cm) on any view
References
Publications (0)
Data not yet available