Evidence map›Paper›PMID 29302784›Full record

ArticleEuropean radiology2018

Initial results of the FUSION-X-US prototype combining 3D automated breast ultrasound and digital breast tomosynthesis.

Benedikt Schaefgen, Joerg Heil, Richard G Barr, Marcus Radicke, Aba Harcos, Christina Gomez, Anne Stieber, André Hennigs, Alexandra von Au, Julia Spratte and 5 more

Abstract readEvaluation Study
PubMed Publisher
In one paragraph

Article in European radiology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Benedikt SchaefgenDepartment of Gynecology and Obstetrics, University Breast Unit, Im Neuenheimer Feld 440, 69120, Heidelberg, Germany.
Joerg HeilDepartment of Gynecology and Obstetrics, University Breast Unit, Im Neuenheimer Feld 440, 69120, Heidelberg, Germany.
Richard G BarrNortheastern Ohio Medical University and Southwoods Imaging, Youngstown, OH, USA.
Marcus RadickeSiemens Healthcare GmbH, Siemensstr. 3, 91301, Forchheim, Germany.
Aba HarcosDepartment of Gynecology and Obstetrics, University Breast Unit, Im Neuenheimer Feld 440, 69120, Heidelberg, Germany.
Christina GomezDepartment of Gynecology and Obstetrics, University Breast Unit, Im Neuenheimer Feld 440, 69120, Heidelberg, Germany.
Anne StieberDepartment of Gynecology and Obstetrics, University Breast Unit, Im Neuenheimer Feld 440, 69120, Heidelberg, Germany.
André HennigsDepartment of Gynecology and Obstetrics, University Breast Unit, Im Neuenheimer Feld 440, 69120, Heidelberg, Germany.
Alexandra von AuDepartment of Gynecology and Obstetrics, University Breast Unit, Im Neuenheimer Feld 440, 69120, Heidelberg, Germany.
Julia SpratteDepartment of Gynecology and Obstetrics, University Breast Unit, Im Neuenheimer Feld 440, 69120, Heidelberg, Germany.
Geraldine RauchInstitute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany.
Joachim RomDepartment of Gynecology and Obstetrics, University Breast Unit, Im Neuenheimer Feld 440, 69120, Heidelberg, Germany.
Florian SchützDepartment of Gynecology and Obstetrics, University Breast Unit, Im Neuenheimer Feld 440, 69120, Heidelberg, Germany.
Christof SohnDepartment of Gynecology and Obstetrics, University Breast Unit, Im Neuenheimer Feld 440, 69120, Heidelberg, Germany.
Michael GolattaDepartment of Gynecology and Obstetrics, University Breast Unit, Im Neuenheimer Feld 440, 69120, Heidelberg, Germany. Michael.Golatta@med.uni-heidelberg.de.ORCID http://orcid.org/0000-0002-2605-0060

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo determine the feasibility of a prototype device combining 3D-automated breast ultrasound (ABVS) and digital breast tomosynthesis in a single device to detect and characterize breast lesions.

methodsIn this prospective feasibility study, the FUSION-X-US prototype was used to perform digital breast tomosynthesis and ABVS in 23 patients with an indication for tomosynthesis based on current guidelines after clinical examination and standard imaging. The ABVS and tomosynthesis images of the prototype were interpreted separately by two blinded experts. The study compares the detection and BI-RADS® scores of breast lesions using only the tomosynthesis and ABVS data from the FUSION-X-US prototype to the results of the complete diagnostic workup.

resultsImage acquisition and processing by the prototype was fast and accurate, with some limitations in ultrasound coverage and image quality. In the diagnostic workup, 29 solid lesions (23 benign, including three cases with microcalcifications, and six malignant lesions) were identified. Using the prototype, all malignant lesions were detected and classified as malignant or suspicious by both investigators.

conclusionSolid breast lesions can be localized accurately and fast by the Fusion-X-US system. Technical improvements of the ultrasound image quality and ultrasound coverage are needed to further study this new device. KEY POINTS: The prototype combines tomosynthesis and automated 3D-ultrasound (ABVS) in one device. It allows accurate detection of malignant lesions, directly correlating tomosynthesis and ABVS data. The diagnostic evaluation of the prototype-acquired data was interpreter-independent. The prototype provides a time-efficient and technically reliable diagnostic procedure. The combination of tomosynthesis and ABVS is a promising diagnostic approach.

Indexed as

AdultAgedBreast NeoplasmsCalcinosisDiagnosis, DifferentialEquipment DesignFeasibility StudiesFemaleHumansImage Interpretation, Computer-AssistedImaging, Three-DimensionalMammographyMiddle AgedMultimodal ImagingProspective StudiesSensitivity and SpecificityBreastCancerMammographyMultimodal ImagingUltrasonography

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Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.