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Decision by sponsor, development stopped.
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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.
Tomosynthesis is a relatively new technology to acquire mammographic images where images are acquired over several projection angles, giving 3d information that can help radiologists assess images.
The aim of the study is to see whether a new low-dose tomosynthesis system has comparable image quality at a lower x-ray radiation dose to a comparator.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tomo Assessment | Experimental | Subjects will have a 4-view tomosynthesis examination with the study device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tomo Assessment | Device | A four-view tomosynthesis examination |
|
| Measure | Description | Time Frame |
|---|---|---|
| X-ray dose | X-ray dose will be measured per projection. | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Lesion conspicuity comparison of images from study device vs comparator | Lesion conspicuity will be assessed by image readers (radiologists) comparing the conspicuity of the same lesion imaged with the study device to the comparator | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pietro Panizza, M.D | Ospedale San Raffaele | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale San Rafaele | Milan | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41045355 | Derived | Venturini 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. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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This is an imaging study. All participants will be imaged using two modalities. All participant data will be deidentified.
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| D017437 |
| Skin and Connective Tissue Diseases |