Clinical trial · Interventional
MBI and Breast Tomosynthesis Screening Accuracies in Patients With Dense Breast Tissue
Pilot Study: Dedicated Dual Head Molecular Breast Imaging Compared to Breast Tomosynthesis for Evaluation of Patients With Type 3 or 4 Mammographic Breast Density
- 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)
Primary: In women with heterogeneous or dense breast tissue (mammographic types 3 and 4), MBI (Molecular Breast Imaging) will detect more breast cancers and have greater sensitivity in detecting breast cancer than breast tomosynthesis. Secondary: 1. In women with heterogeneous or dense breast tissue, the specificity of MBI in correctly classifying subjects without breast cancer will be non-inferior to breast tomosynthesis. 2. In women with heterogeneous or dense breast tissue, the area under the receiver operating characteristic (ROC) curve for MBI will be non-inferior or superior to breast tomosynthesis. 3. Combining the use of MBI and breast tomosynthesis will provide performance superior to either technology alone, as manifest by a superior ROC curve area.
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 Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3D Mammogram/Breast Tomosynthesis Scan: Selenia® Dimensions® | Device | — | UNRESOLVED |
| MBI Scan: The LumaGEM® | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MBI Scan & Tomosynthesis Scan
- description
- Patients will receive both scans.
- interventionNames
- Device: MBI Scan: The LumaGEM®
- Device: 3D Mammogram/Breast Tomosynthesis Scan: Selenia® Dimensions®
Primary outcomes (1)
- measure
- Sensitivity/Cancer detection
- timeFrame
- 12 months
- description
- Sensitivity being the number of scans read or labeled positive (by radiologist) divided by the total cancers confirmed by pathology results (i.e. biopsy).
Secondary outcomes (1)
- measure
- Specificity
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
Show eligibility criteria text
Inclusion Criteria: * Women over 25 years of age with normal or increased risk of breast cancer. * Women with type 3 or 4 breast density as determined by a breast imaging radiologist on a current unilateral (women with prior mastectomy) or bilateral mammography (within prior 6 weeks). * No contraindications to breast MBI or breast tomosynthesis. Exclusion Criteria: * Women under the age of 25. * Women who are or may be pregnant. * Women who are currently lactating or have discontinued breast feeding \< 2 months prior to the study. * Male patients are excluded as subjects. * Those unable or unwilling to provide informed consent.
References
Publications (0)
Data not yet available