Evidence map›Paper›PMID 34136936›Full record

Trial reportAbdominal radiology (New York)2021

Prospective assessment of diagnostic efficacy and safety of Sonazoid

Ke Lv, Hongyan Zhai, Yuxin Jiang, Ping Liang, Hui-Xiong Xu, Lianfang Du, Yi-Hong Chou, Xiaoyan Xie, YuKun Luo, Young Joon Lee and 9 more

Abstract readClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Abdominal radiology (New York), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 1 pooled it
–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

23 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Guideline
  2. Article
  3. Microvascular Imaging of Hepatic Hemangiomas.Diagnostics (Basel, Switzerland) · 2025
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  16. Review
  17. Review
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  19. Article
  20. Sonazoid™ versus SonoVueKorean journal of radiology · 2022
    Article
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

19 authors.

Ke Lv *Department of Ultrasound, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, 100730, China.
Hongyan Zhai *Tianjin Medical University General Hospital, Tianjin, China.
Yuxin Jiang *Department of Ultrasound, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, 100730, China. yuxinxhjiang@163.com.
Ping Liang *Chinese PLA General Hospital, Beijing, China.
Hui-Xiong XuShanghai Tenth People's Hospital, Tongji University, Shanghai, China.
Lianfang DuShanghai First People's Hospital, Shanghai, China.
Yi-Hong ChouTaipei Veterans General Hospital, Taipei, China.
Xiaoyan XieThe First Affiliated Hospital of Sun-Yatsen University, Guangzhou, China.
YuKun LuoChinese PLA General Hospital, Beijing, China.
Young Joon LeeSeoul St. Mary's Hospital, Seoul, South Korea.
Jae Young LeeSeoul National University Hospital, Seoul, South Korea.
Bing HuShanghai Sixth Hospital, Shanghai, China.
Baoming LuoSun Yet-Sen Memorial Hospital, Sun Yet-Sen University, Guangzhou, China.
Yi WangShanghai Hua Shan Hospital, Fudan University, Shanghai, China.
Ying LuanGE HealthcareLife Sciences, Piscataway, USA.
Christina KalliGE HealthcareLife Sciences, Piscataway, USA.
Kun ChenGE HealthcareLife Sciences, Piscataway, USA.
Wenping WangZhongshan Hospital Fudan University, Shanghai, China.
Ja-Der LiangNational Taiwan University Hospital, Taipei, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo assess the respective diagnostic value of Sonazoid™ and SonoVue® for characterizing FLLs as benign or malignant and the corresponding safety.

methodsThis prospective Phase 3 study was conducted at 17 centres in China and Korea (May 2014 to April 2015); 424 patients (20 to 80 years) with at least 1 untreated focal liver lesion (FLL) (< 10 cm in diameter) underwent a contrast-enhanced ultrasound (CEUS) examination (218 received Sonazoid of 0.12 μL microbubbles/kg; 206 received SonoVue of 2.4 mL). Three independent blinded readers evaluated pre- and post-contrast images characterising the FLLs as benign or malignant.

resultsSonazoid-enhanced and SonoVue-enhanced ultrasound provided a statistically significant improvement in specificity for all 3 readers comparing to unenhanced ultrasound (for Sonazoid: p = 0.0093, < 0.0001, 0.0011; for SonoVue: p = 0.002, 0.03, 0.12, respectively). Difference in accuracy improvement between the 2 groups was within the pre-specified non-inferiority margin of 20% for all 3 readers (6.1%, 95% CI: - 5.0 to 17.2; - 7.5%, 95% CI: - 18.4 to 3.5; - 0.3%, 95% CI: - 11.3 to 10.7). The diagnostic confidence level for all 3 readers increased with post-contrast images relative to pre-contrast images. Both contrast agents were well tolerated.

conclusionResults showed a similar efficacy for Sonazoid™ and SonoVue® in diagnosing FLLs as benign or malignant, and underlined the benefit of CEUS imaging over unenhanced ultrasound imaging in reaching a confident diagnosis without having to refer patients for additional imaging exams.

Indexed as

Contrast MediaLiver NeoplasmsFerric CompoundsHumansIronLiverOxidesPhospholipidsProspective StudiesSensitivity and SpecificitySulfur HexafluorideUltrasonographycontrast agent BR1Contrast MediaFerric CompoundsIronOxidesPhospholipidsSonazoidSulfur HexafluorideCharacterizationContrast-enhanced ultrasoundDiagnostic accuracyFocal liver lesionsVascular imaging

Identifiers

PMID34136936
PMCPMC8435522

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Registered trials

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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.