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Sonovue (Lumason / Sonovue / BR1)

✓ Approved

Bracco · Small Molecule · Small Molecule

What is Sonovue?

Sonovue is a small molecule developed by Bracco. It is approved for therapeutic indications via injectable (others) or intravenous (iv).

Drug Profile

Brand NamesLumason, Sonovue, BR1
CompanyBracco
Drug ClassSmall Molecule, Imaging Agents
RouteInjectable (Others), Intravenous (IV)
StatusApproved
Sources: ClinicalTrials.gov, Bracco

Therapeutic Indications

Sonovue is developed for 3 unique indications across 3 therapeutic areas.

Therapeutic AreaConditionPhase
Cardiac disordersArteriosclerosis coronary artery✓ Approved
InvestigationsBlood pressure increased✓ Approved
Neoplasms benign, malignant and unspecified (incl cysts and polyps)Uterine cancer✓ Approved

Related Research Articles

PubMedMedicina clinica2026-08-25

Feasibility and characteristics of contrast-enhanced lung ultrasound in the diagnosis of pulmonary embolism in hospitalized patients.

Tung-Chen Yale Y, González Cecilio Juan Ignacio JI, Ferrer-Reyes Guillermo G, Gómez-Rojas Maria Agustina MA et al.

Lung ultrasound (LUS) is a complementary tool in pulmonary embolism (PE) when computed tomography pulmonary angiography (CTPA) is delayed or contraindicated. Contrast-enhanced ultrasound (CEUS) enables real-time perfusion assessment and may help characterize subpleural consolidations. We aimed to describe the feasibility and findings of LUS/CEUS in hospitalized PE and to explore the association between enhancement patterns and atelectasis. Retrospective single-center study (September-December 2025) including Internal Medicine inpatients with a final diagnosis of PE and reference imaging (CTPA and/or V/Q scintigraphy). CEUS was performed with SonoVue®; enhancement was classified as absent, heterogeneous, or homogeneous/hyperenhancing. Descriptive analyses and exploratory Fisher's exact tests were performed in the subgroup with consolidations evaluable by CEUS. Thirty-four patients were included (38.2% women). CTPA was performed in 33/34 and was positive in 32; two V/Q scans were performed, both high probability. LUS detected subpleural consolidations in 28/34 (82.4%), with a median of 2lesions per patient; localized pleural effusion was found in 24/33 (72.7%). CEUS was performed in 28/33; among patients with consolidation and CEUS (n=28), absent enhancement predominated (64.3%), followed by heterogeneous enhancement (25.0%) and homogeneous/hyperenhancement (10.7%). Homogeneous/hyperenhancement was associated with atelectasis (P=.017), whereas absent enhancement was associated with less atelectasis (P=.026). LUS and CEUS were feasible in hospitalized patients with PE, and CEUS provided additional perfusion information for characterizing subpleural consolidations.

PMID 42641494
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PubMedJournal of pediatric surgery2026-08-09

Contrast-enhanced Colonosonography in AnoRectal malformations (CoCo-ARM) study.

Westwood Esther E, Bhardwaj Andrea A, Lloyd Clare C, Urquia Arlen A et al.

Fluoroscopic colostography (FC) is the gold-standard modality to plan definitive surgery in anorectal malformation (ARM). Contrast-enhanced colosonography (CeCS) can be used in this context. We conducted a prospective, single-centre study comparing the accuracy of CeCS with FC. Male patients with ARM awaiting reconstructive surgery were recruited during a 12-month period. CeCS using SonoVue were performed and reported contemporaneously by two investigating consultant radiologists. FCs were performed departmentally. All studies were reported as anonymised, unlinked studies by a third blinded consultant. The anonymised studies were reported with a Likert score to denote confidence in the findings. Findings were compared between the two imaging techniques and at operation. 11 patients were included. There was agreement in 8/11 (73%) patients between the two modalities. Beaking was seen at FC without a clear fistula in 2 cases, but was demonstrated clearly on CeCS. In the eleventh case, FC demonstrated a potential perineal fistula; there was poor filling of the distal limb using initial CeCS. This study was repeated under GA combined with cystoscopy, clearly identifying a recto-prostatic fistula. There was agreement in 100% of cases during blinded review of the CeCS with a mean Likert rating of 1.6 (SD = 0.64). In 10/10 (100%) of those who have undergone reconstructive surgery, CeCS findings were consistent with operative findings. CeCS is equivalent, if not superior to, FC in accurately identifying the fistular anatomy in males with anorectal malformations. Studies can be reviewed and reported with a high degree of diagnostic confidence.

PMID 42551510
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PubMedJournal of ultrasound2026-07-28

Diagnostic accuracy of contrast-enhanced ultrasound versus duplex ultrasound and computed tomography angiography for endoleak detection after EVAR: a prospective comparative study.

Lustre Wellington Gianoti WG, Leal Libnah L, Cardoso Vinicius V, Cristino Mateus Aves Borges MAB et al.

Lifelong imaging surveillance after endovascular aneurysm repair (EVAR) is essential for endoleak detection but is limited by cumulative radiation and nephrotoxicity from computed tomography angiography (CTA). Contrast-enhanced ultrasound (CEUS) has emerged as a promising alternative, although prospective comparative data remain limited. In this prospective, single-centre diagnostic accuracy study, 30 consecutive patients (mean age 78.5 ± 7.1 years; 70% male) undergoing EVAR follow-up were evaluated with duplex ultrasound (DUS), CEUS (SonoVue®), and CTA within a 30-day interval. CTA served as the reference standard. Diagnostic performance metrics were calculated with 95% confidence intervals (CIs) according to STARD recommendations. Endoleaks were identified in 11 patients (36.7%). CTA detected 8 cases (26.7%), CEUS 9 (30.0%), and DUS 4 (13.3%). CEUS demonstrated high sensitivity (87.5%; 95% CI 47.3-99.7%) and specificity (90.9%; 70.8-98.9%), with overall accuracy of 90.0% (73.5-97.9%). In contrast, DUS showed limited sensitivity (33.3%; 9.9-65.1%) despite perfect specificity (100%), yielding lower accuracy (73.3%). Inter-modality agreement was 83.3%. CEUS demonstrates high diagnostic accuracy for endoleak detection after EVAR and represents a robust, radiation-free alternative to CTA for longitudinal surveillance. Given its favourable safety profile and diagnostic performance, CEUS should be considered a first-line imaging modality in routine follow-up, with CTA reserved for equivocal findings or pre-interventional planning. These results support a paradigm shift toward CEUS-based surveillance strategies.

PMID 42509453
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PubMedJournal of clinical ultrasound : JCU2026-06-29

Noninvasive Preoperative Assessment of Sentinel Lymph Node Metastasis in Breast Cancer Using Super-Resolution Ultrasound Microvascular Imaging.

Guo Ruifang R, Liu Xi X, Zhao Junfeng J, Hu Xiangdong X et al.

To develop and internally validate a super-resolution ultrasound microvascular imaging (SR-UMI) model for noninvasive preoperative prediction of sentinel lymph node (SLN) involvement in breast cancer and to assess incremental value over clinical variables. In this prospective single-center study (January-June 2025), 162 consecutive patients with pathologically confirmed breast cancer underwent contrast-enhanced SR-UMI of the primary tumor prior to axillary surgery and SLNB. SonoVue (2.4 mL) was administered as an antecubital venous bolus. Examinations were performed on an Ultimus 9E ultrasound system using a 5-15 MHz linear transducer at low MI (0.08). Three predictor sets were evaluated: clinical-only (9 variables), SR-UMI-only (98 features), and combined (107 predictors). Elastic net-regularized logistic regression (EN-LR) was prespecified as the primary model and evaluated using nested stratified cross-validation (outer 5-fold, inner 3-fold) with pooled out-of-fold (OOF) predictions, assessing discrimination, calibration, and decision-curve analysis (DCA). SLN involvement was present in 55/162 patients (34.0%). EN-LR achieved AUC 0.662, PR-AUC 0.471, and Brier 0.232 for clinical-only predictors; SR-UMI-only improved performance (AUC 0.800; PR-AUC 0.572; Brier 0.185). The combined model performed similarly (AUC 0.802; PR-AUC 0.574; Brier 0.185). At the Youden operating point (threshold 0.514), the combined model yielded sensitivity 0.782, specificity 0.766, PPV 0.632, and NPV 0.872. Bootstrap OOF comparisons showed significant AUC improvements for SR-UMI-only versus clinical-only and combined vs. clinical-only, whereas combined vs. SR-UMI-only was not significant. Calibration showed a negative intercept and slope > 1 (combined: -0.637, 1.270). DCA demonstrated higher net benefit for EN-LR than treat-all/treat-none across threshold probabilities 0.05-0.60. SR-UMI microvascular features enabled good internal-validation performance and significantly improved discrimination over clinical/biopsy variables. The combined model offered no meaningful gain over SR-UMI only. External validation with recalibration is warranted.

PMID 42366496
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PubMedVeterinary radiology & ultrasound : the official journal of the American College of Veterinary Radiology and the International Veterinary Radiology Association2026-05-31

Renal Perfusion in Healthy Horses: A Feasibility Study With Contrast-Enhanced Ultrasound.

Salazar Diana Villa Verde DVV, Ferreira Marília Alves MA, Brito Pedro Henrique Salles PHS, Uscategui Ricardo Andrés Ramirez RAR et al.

This study assessed the feasibility of contrast-enhanced ultrasound (CEUS) for evaluating renal perfusion in horses and compared perfusion parameters between age groups. In a prospective study, eight healthy horses were divided into young (3-5 years, n = 4) and old (16-17 years, n = 4) groups. All animals underwent B-mode, Doppler ultrasonography, and CEUS of the right kidney after an intravenous bolus of SonoVue (0.02 mL/kg). Qualitative analysis assessed contrast kinetics, whereas quantitative parameters (peak intensity, time to peak [TP], area under the curve, and wash-out time) were obtained from time-intensity curves in the renal cortex and medulla. The technique was safely performed in all horses, and the 0.02 mL/kg dose proved optimal for achieving adequate renal enhancement and consistent quantitative measurements. Quantitative analysis revealed a significantly longer TP in the renal cortex of older horses compared to young ones (p = 0.03), suggesting an age-related reduction in perfusion velocity. No other parameters showed significant differences. CEUS proved to be a feasible and safe method for assessing renal perfusion in horses. The prolonged cortical TP in older animals indicates that CEUS may be a sensitive tool for detecting early, subclinical perfusion changes associated with aging, warranting further investigation in horses with renal disease.

PMID 42216711
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PubMedEuropean journal of pediatrics2026-05-21

Microvascular ultrasound imaging of the neonatal brain: a scoping review.

Ramana Anoop A, Zhu Jingwen J, Acimovic Ksenija K, Mitra Kalyan K et al.

Microvascular changes in the developing neonatal brain often precede clinically detectable injury. Advanced ultrasound techniques such as microvascular Doppler (MVD), contrast-enhanced ultrasound (CEUS), and super-resolution ultrasound (SRUS) offer the potential for bedside assessment of microvascular flow and perfusion without sedation, organotoxic contrast agents, or ionising radiation. Using Joanna Briggs Institute methodology and PRISMA-ScR guidance, MEDLINE, EMBASE, Web of Science, trial registries, and grey literature were searched for original in vivo neonatal studies reporting microvascular or perfusion data using MVD, CEUS, or SRUS-based approaches. Extracted data included study metadata, population characteristics, ultrasound systems and protocols, and key feasibility, safety, and performance outcomes. Of 3028 screened records, 23 studies met the inclusion criteria (1 SRUS, 8 CEUS, 14 MVD). Using SonoVue/Lumason microbubbles, the CEUS studies reported 163 neonatal brain scans in 91 neonates (25+3 to 41+4 weeks' gestation). A total of 263 infants were studied across 14 MVD studies. All studies demonstrated safe ultrasound techniques that can be used to assess brain perfusion and cerebrovascular pathologies in preterm and term neonates, particularly in understanding changes in cerebral microvasculature, mainly in infants with hypoxic-ischaemic encephalopathy (HIE), neurovascular, and congenital cardiac conditions. Conclusions: Advanced ultrasound techniques show promise as adjuncts in neonatal neuroimaging, enabling assessment of perfusion and microvascular haemodynamics. Future clinical translation would require standardised protocols, normative datasets, longitudinal outcome linkage, governance and training standards, and diagnostic effectiveness.

PMID 42162396
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