Clinical trial · Interventional
Molecular Breast Imaging (MBI)-Guided Biopsy
Molecular Breast Imaging (MBI)-Guided Biopsy Pilot SBIR
- 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 goal of this pilot clinical trial is to demonstrate supplemental screening MBI (molecular breast imaging) in women with dense breasts. The main questions it aims to answer are: * Does screening MBI find more cancer than screening DBT (3D mammography, digital breast tomosynthesis? * Does screening MBI result in more call-backs for biopsy than DBT? * How well does MBI-guided biopsy conform with pathology reports? Researchers will compare screening MBI to screening DBT to see if MBI is more sensitive to detecting cancer in women with dense breasts. Participants will * Receive both screening DBT and screening MBI * Receive either DBT-guided or MBI-guided biopsy (randomly assigned), if required by the screening images
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biopsy | — | UNRESOLVED | — |
| Breast Cancer Detection | — | UNRESOLVED | — |
| Breast Neoplasm | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Dense Breasts | — | UNRESOLVED | — |
| Molecular Imaging | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MBI-guided biopsy | Device | — | UNRESOLVED |
| Molecular Breast Imaging | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- ACTIVE_COMPARATOR
- label
- Breast screening
- description
- Screening DBT and screening MBI are compared in women with dense breasts. Then, DBT-guided biopsy and MBI-guided biopsy are compared.
- interventionNames
- Device: Molecular Breast Imaging
- Device: MBI-guided biopsy
Primary outcomes (1)
- measure
- Cancer Detection Rate
- timeFrame
- less than one day
- description
- The number of cancers found by a particular modality compared to the number of women with dense breasts screened by that modality.
Secondary outcomes (3)
- measure
- Concordance Rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * dense breasts (BI-RADS C or D) on screening DBT Exclusion Criteria: * pregnancy
References
Publications (0)
Data not yet available