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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

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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PubMedAdvanced science (Weinheim, Baden-Wurttemberg, Germany)2026-05-13

ROS-Responsive Nanobubbles for Dual-Enhanced Ultrasound and Magnetic Resonance Imaging of Tumor Oxidative Stress.

Jung Wonsik W, Son Youngju Y, Lee Dong Yun DY, Jeon Youngeun Y et al.

Reactive oxygen species (ROS) are key biomarkers of oxidative stress in the tumor microenvironment (TME), yet their non-invasive, real-time visualization remains challenging. Here, we present biotinylated PEGylated bilirubin nanobubbles encapsulating perfluoropentane gas (bt-PEG-BR@PFP) as ROS-responsive contrast agents for dual-modality ultrasound (US) and magnetic resonance imaging (MRI). Upon ROS exposure, the bilirubin shell undergoes oxidative degradation, leading to nanobubble fusion and signal amplification in both US and T2*-weighted MRI. In vitro, biotin-mediated cellular uptake and ROS-induced fusion were validated in A549 cancer cells. In vivo, intratumoral injection of bt-PEG-BR@PFP into dual-tumor xenografts led to a >3.7-fold increase in US signal intensity in ROS-high A549 tumors compared to ROS-low DU145 tumors, which was abolished by the ROS scavenger N-acetylcysteine. Following systemic administration, the nanobubbles accumulated selectively in A549 tumors through biotin-mediated targeting and produced ∼50-fold higher US signal than in DU145 tumors. In contrast, the clinical agent SonoVue showed no such tumor selectivity and ROS-responsive signal enhancement. MRI studies revealed a time-dependent signal drop only in A549 tumors treated with bt-PEG-BR@PFP, consistent with ROS-mediated nanobubble fusion. These results highlight bt-PEG-BR@PFP as a promising and clinically translatable platform for non-invasive, dual-modality imaging of tumor oxidative stress, with potential utility in various ROS-associated pathologies.

PMID 42126812
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PubMedDiagnostics (Basel, Switzerland)2026-05-04

Splenoses and Other Ectopic and Heterotopic Splenic Tissue: The Use of Long-Lasting Enhancement in Contrast-Enhanced Ultrasound to Avoid Unnecessary Intervention.

Möller Kathleen K, Faiss Siegbert S, Lim Adrian A, Jenssen Christian C et al.

This narrative review describes variants of heterotopic and ectopic spleen tissue, focusing on its appearance under contrast-enhanced ultrasound (CEUS) with SonoVue (SonoVue®; Bracco, Milano, Italy). Typical feature of splenic tissue with SonoVue is its long-lasting enhancement. The diagnosis of these splenic variants, in the vast majority of cases, has primarily been performed with CT, MRI, spleen-specific scintigraphy, or image-guided biopsy. In this review, we analyze published cases and also include our own case examples where CEUS has been used, and describe the enhancement characteristics of splenosis and atypical (intrapancreatic) accessory spleens. CEUS can provide valuable diagnostic information in patients with suspected ectopic splenic tissue, particularly when interpreted together with clinical history and complementary imaging modalities. Ultimately, ectopic splenic tissue should be considered, especially after splenectomy or splenic trauma, in cases of well-defined, hypervascularized lesions where CEUS may help avoid unnecessary invasive procedures in selected cases.

PMID 42072796
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PubMedJournal of clinical ultrasound : JCU2026-04-07

Analysis of the Safety of Single-Center Contrast-Enhanced Ultrasound in Pediatric Patients.

Song Lanxin L, Yang Xiuzhen X, Qian Jingjing J, Yu Jin J et al.

This study retrospectively analyzed the safety of sulfur hexafluoride microbubble contrast-enhanced ultrasound (CEUS) in 447 pediatric patients (median age 8 years 4 months) at a single center. Using weight-based dosing (≤ 0.03 mL/kg of SonoVue), the overall adverse event incidence was 1.6% (7/447). Events included nausea/vomiting, severe cough, headache, rash, and transient hypertension, all mild and transient with no serious outcomes. All seven events were classified as mild, and no serious adverse events (e.g., anaphylactic shock, laryngeal edema) occurred in this study. No significant differences were found across gender or age groups. With standardized procedure and monitoring, CEUS demonstrated a highly favorable safety profile as a valuable radiation-free imaging tool in pediatrics.

PMID 41943124
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