Clinical trial · Interventional
Low Dose Tomosynthesis Compared to Traditional Tomosynthesis
NCT02771444CI-TRIAL-00032230terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Decision by sponsor, development stopped.
Summary
Brief summary (as posted)
This study aims to evaluate image quality of a low-dose tomosynthesis system versus a comparator. Subjects will undergo a four-view tomosynthesis examination with the comparator and with the study device, and images will be assessed by several radiologists by comparing details in the images from the two systems.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tomo Assessment | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tomo Assessment
- description
- Subjects will have a 4-view tomosynthesis examination with the study device.
- interventionNames
- Device: Tomo Assessment
Primary outcomes (1)
- measure
- X-ray dose
- timeFrame
- 4 months
- description
- X-ray dose will be measured per projection.
Secondary outcomes (1)
- measure
- Lesion conspicuity comparison of images from study device vs comparator
- timeFrame
- 4 months
- description
- Lesion conspicuity will be assessed by image readers (radiologists) comparing the conspicuity of the same lesion imaged with the study device to the comparator
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Woman over 40 years of age * Has a tomosynthesis examination with comparator * Has a mammographic finding Exclusion Criteria: * Pregnant, breastfeeding or believes she may be pregnant * Unable or unwilling to give informed consent
References
Publications (1)
- DERIVEDVenturini E, Losio C, Rodighiero M, Ferrarese G, Del Vecchio A, Loria A, Rehn JR, Panizza P. Low dose photon-counting digital breast tomosynthesis: comparison with a commercially available tomosynthesis unit in the detection and characterization of breast carcinomas. Radiol Med. 2026 Jan;131(1):11-20. doi: 10.1007/s11547-025-02115-7. Epub 2025 Oct 4. PMID 41045355