Evidence map›Paper›PMID 33313983›Full record

ArticleEuropean radiology2021

Evaluation of the FUSION-X-US-II prototype to combine automated breast ultrasound and tomosynthesis.

Benedikt Schäfgen, Marija Juskic, Marcus Radicke, Madeleine Hertel, Richard Barr, André Pfob, Riku Togawa, Juliane Nees, Alexandra von Au, Sarah Fastner and 8 more

Open access · hybridAbstract read
In one paragraph

Article in European radiology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.4field-weighted citation impact, top 15% of its field
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

7 citing papers in PubMed, 16 citations in OpenAlex.

  1. Article
  2. Article
  3. Evolution of tomosynthesis.Journal of medical imaging (Bellingham, Wash.) · 2025
    Review
  4. Article
  5. Article
  6. Article
  7. A Review of Breast Imaging for Timely Diagnosis of Disease.International journal of environmental research and public health · 2021
    Review
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

18 authors at 3 institutions in 2 countries.

Benedikt SchäfgenDepartment of Gynecology and Obstetrics, University Breast Unit, Heidelberg, Germany.
Marija JuskicDepartment of Gynecology and Obstetrics, University Breast Unit, Heidelberg, Germany.
Marcus RadickeSiemens Healthcare GmbH, Forchheim, Germany.
Madeleine HertelSiemens Healthcare GmbH, Forchheim, Germany.
Richard BarrNortheastern Ohio Medical University and Southwoods Imaging, Youngstown, OH, USA.
André PfobDepartment of Gynecology and Obstetrics, University Breast Unit, Heidelberg, Germany.
Riku TogawaDepartment of Gynecology and Obstetrics, University Breast Unit, Heidelberg, Germany.
Juliane NeesDepartment of Gynecology and Obstetrics, University Breast Unit, Heidelberg, Germany.
Alexandra von AuDepartment of Gynecology and Obstetrics, University Breast Unit, Heidelberg, Germany.
Sarah FastnerDepartment of Gynecology and Obstetrics, University Breast Unit, Heidelberg, Germany.
Aba HarcosDepartment of Gynecology and Obstetrics, University Breast Unit, Heidelberg, Germany.
Christina GomezDepartment of Gynecology and Obstetrics, University Breast Unit, Heidelberg, Germany.
Anne StieberDepartment of Radiology, University Breast Unit, Heidelberg, Germany.
Fabian RiedelDepartment of Gynecology and Obstetrics, University Breast Unit, Heidelberg, Germany.
André HennigsDepartment of Gynecology and Obstetrics, University Breast Unit, Heidelberg, Germany.
Christof SohnDepartment of Gynecology and Obstetrics, University Breast Unit, Heidelberg, Germany.
Joerg HeilDepartment of Gynecology and Obstetrics, University Breast Unit, Heidelberg, Germany.
Michael GolattaDepartment of Gynecology and Obstetrics, University Breast Unit, Heidelberg, Germany. Michael.Golatta@med.uni-heidelberg.de.ORCID http://orcid.org/0000-0002-2605-0060
Siemens Healthineers (Germany) · DEHeidelberg University · DENortheast Ohio Medical University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe FUSION-X-US-II prototype was developed to combine 3D automated breast ultrasound (ABUS) and digital breast tomosynthesis in a single device. We evaluated the performance of ABUS and tomosynthesis in a single examination in a clinical setting.

methodsIn this prospective feasibility study, digital breast tomosynthesis and ABUS were performed using the FUSION-X-US-II prototype without any change of the breast position in patients referred for clarification of breast lesions with an indication for tomosynthesis. The tomosynthesis and ABUS images of the prototype were interpreted independently from the clinical standard by a breast diagnostics specialist. Any detected lesion was classified using BI-RADS® scores, and results of the standard clinical routine workup (gold standard) were compared to the result of the separate evaluation of the prototype images. Image quality was rated subjectively and coverage of the breast was measured.

resultsOne hundred one patients received both ABUS and tomosynthesis using the prototype. The duration of the additional ABUS acquisition was 40 to 60 s. Breast coverage by ABUS was approximately 80.0%. ABUS image quality was rated as diagnostically useful in 86 of 101 cases (85.1%). Thirty-three of 34 malignant breast lesions (97.1%) were identified using the prototype.

conclusionThe FUSION-X-US-II prototype allows a fast ABUS scan in combination with digital breast tomosynthesis in a single device integrated in the clinical workflow. Malignant breast lesions can be localized accurately with direct correlation of ABUS and tomosynthesis images. The FUSION system shows the potential to improve breast cancer screening in the future after further technical improvements. KEY POINTS: • The FUSION-X-US-II prototype allows the combination of automated breast ultrasound and digital breast tomosynthesis in a single device without decompression of the breast. • Image quality and coverage of ABUS are sufficient to accurately detect malignant breast lesions. • If tomosynthesis and ABUS should become part of breast cancer screening, the combination of both techniques in one device could offer practical and logistic advantages. To evaluate a potential benefit of a combination of ABUS and tomosynthesis in screening-like settings, further studies are needed.

Indexed as

Breast NeoplasmsUltrasonography, MammaryBreastFemaleHumansMammographyProspective StudiesSensitivity and SpecificityEarly detection of cancerImaging, three-dimensionalMammographyMultimodal imagingUltrasonography, mammary

Identifiers

PMID33313983
PMCPMC8128739
OpenAlexW3110873154

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.