Drugs / Lumason
Lumason
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (3) | US (FDA) | LUMASON | — | 2016-03-31 – 2019-11-13 | fda.gov ↗ |
| Approved | US (FDA) | LUMASON | — | 2014-10-10 | fda.gov ↗ |
| Approved | EU (EMA) | SonoVue | — | 2001-03-26 | europa.eu ↗ |
Trials 45
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 03 trials | ||||||
| Phase 0 | NCT05957042 | Sep 2023 → Sep 2026 | breast cancer | Milton S. Hershey Medical Center | Withdrawn | No outcome recorded |
| Phase 0 | NCT03954015 | Oct 2019 → Jun 2020 | breast fibrocystic change, proliferative type | Mayo Clinic | Completed | No outcome recorded |
| Phase 0 | NCT03107520 | May 2017 → Apr 2027 expected | developmental dysplasia of the hip | Children's Hospital of Philadelphia | Recruiting | No outcome recorded |
| Phase 15 trials | ||||||
| Phase 1 | NCT03653702 | Oct 2023 → Apr 2024 | vesicoureteral reflux | Boston Children's Hospital | Unknown | No outcome recorded |
| Phase 1 | NCT05613946 | Dec 2022 → Jun 2024 | lymphedema | Mayo Clinic | Completed | No outcome recorded |
| Phase 1 | NCT03295656 | Jul 2020 | appendicitis | Boston Children's Hospital | Withdrawn | No outcome recorded |
| Phase 1 | NCT04324294 | Feb 2020 → Dec 2025 | malignant pancreatic neoplasm, pancreatitis | Cedars-Sinai Medical Center | Unknown | No outcome recorded |
| Phase 1 | NCT02911714 | Feb 2018 → Jun 2022 | — | University of Utah | Terminated | No outcome recorded Stop: Business |
| Phase 1/24 trials | ||||||
| Phase 1/2 | NCT05186415 | Aug 2022 → Jun 2024 | pulmonary valve insufficiency, tetralogy of fallot | Nemours Children's Clinic | Completed | No outcome recorded |
| Phase 1/2 | NCT04718441 | May 2021 → May 2025 | abdominal wall malformation | David Mooney | Completed | No outcome recorded |
| Phase 1/2 | NCT03147690 | Nov 2017 → Oct 2019 | — | David Mooney | Terminated | No outcome recorded |
| Phase 1/2 | NCT00286559 | Aug 2006 → Dec 2008 | coronary artery disorder | University Hospital, Basel, Switzerland | Withdrawn | No outcome recorded |
| Phase 25 trials | ||||||
| Phase 2 | NCT06693752 | Oct 2026 → Sep 2027 expected | hydrocephalus | Children's Hospital of Philadelphia | Recruiting | No outcome recorded |
| Phase 2 | NCT04146441 | Feb 2020 → Dec 2022 | pancreatic ductal adenocarcinoma | St. Olavs Hospital | Completed | No outcome recorded |
| Phase 2 | NCT03687502 | Jan 2019 → Mar 2021 | appendicitis | Children's Mercy Hospital Kansas City | Completed | No outcome recorded |
| Phase 2 | NCT03335033 | Nov 2017 → Jan 2022 | arterial disorder | Mayo Clinic | Completed | No outcome recorded |
| Phase 2 | NCT01306292 | Apr → Nov 2011 | pulmonary hypertension | Bracco Diagnostics, Inc | Completed | No outcome recorded |
| Phase 315 trials · 1 met primary | ||||||
| Phase 3 | NCT06497959 | Apr 2025 → Apr 2029 expected | fetal growth restriction | Central Hospital, Nancy, France | Recruiting | No outcome recorded |
| Phase 3 | NCT06496971 | Nov 2024 → Dec 2026 expected | adult glioblastoma, brain cancer | NaviFUS Corporation | Recruiting | No outcome recorded |
| Phase 3 | NCT05648812 | Jan 2024 → Jul 2029 expected | perinatal asphyxia | Turku University Hospital | Recruiting | No outcome recorded |
| Phase 3 | NCT05694611 | Jan 2024 → Jan 2026 | — | Turku University Hospital | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT03549520 | Dec 2020 → May 2024 | brain hypoxia - ischemia | Children's Hospital of Philadelphia | Completed | No outcome recorded |
| Phase 3 | NCT03549507 | Nov 2020 → May 2024 | ischemic bowel disorder, perinatal necrotizing enterocolitis | Children's Hospital of Philadelphia | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT04006275 | Jun → Dec 2019 | cirrhosis of liver, hepatocellular carcinoma | Second Affiliated Hospital, School of Medicine, Zhejiang University | Unknown | No outcome recorded |
| Phase 3 | NCT03290053 | Nov 2017 → Apr 2018 | ischemic stroke | Umeå University | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT02884297 | Oct 2016 → Sep 2019 | pregnancy disorder | Centre Hospitalier Régional Metz-Thionville | Completed | No outcome recorded |
| Phase 3 | NCT02552238 | Oct 2015 → Jun 2017 | coronary artery disorder | Bracco Diagnostics, Inc | Completed | Met primary |
| Phase 3 | NCT02522481 | Sep 2015 → Nov 2017 | coronary artery disorder | Bracco Diagnostics, Inc | Completed | Mixed |
| Phase 3 | NCT00829413 | Jun 2010 → Jul 2013 | liver and intrahepatic bile duct neoplasm | Bracco Diagnostics, Inc | Completed | Mixed |
| Phase 3 | NCT00788697 | Sep 2009 → Jul 2013 | hepatobiliary neoplasm | Bracco Diagnostics, Inc | Completed | Mixed |
| Phase 3 | NCT00911027 | Feb 2009 → Mar 2011 | prostate cancer | Bracco Diagnostics, Inc | Terminated | No outcome recorded |
| Phase 3 | NCT00000140 | Sep 1985 → ? | proliferative vitreoretinopathy, retinal detachment | National Eye Institute (NEI) | Completed | No outcome recorded |
| Phase 47 trials | ||||||
| Phase 4 | NCT05025449 | Sep 2021 → Sep 2023 | — | Emory University | Completed | No outcome recorded |
| Phase 4 | NCT04660136 | Dec 2020 → Mar 2023 | Crohn disease | Yonsei University | Unknown | No outcome recorded |
| Phase 4 | NCT03821376 | Jul 2019 → Sep 2021 | kidney cancer | Indiana University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT03490929 | Jun 2018 → Dec 2026 expected | — | Children's Hospital of Philadelphia | Recruiting | No outcome recorded |
| Phase 4 | NCT03473249 | May 2018 → Dec 2026 expected | — | Children's Hospital of Philadelphia | Active not recruiting | No outcome recorded |
| Phase 4 | NCT03061045 | Apr 2017 → Jan 2018 | hydrocephalus | Johns Hopkins University | Withdrawn | No outcome recorded |
| Phase 4 | NCT03040323 | Dec 2016 → Jun 2018 | — | Indiana University | Terminated | No outcome recorded Stop: Enrollment |
| Phase not applicable6 trials | ||||||
| — | NCT03101176 | Sep 2017 → Sep 2022 | prostate cancer | Academic Medical Center - University of Amsterdam | Unknown | No outcome recorded |
| — | NCT02177045 | Oct 2014 → Oct 2015 | breast cancer | Rambam Health Care Campus | Unknown | No outcome recorded |
| — | NCT01481441 | Nov 2011 → Nov 2015 | prostate cancer | Academic Medical Center - University of Amsterdam | Terminated | No outcome recorded |
| — | NCT00677963 | Jun 2009 → Apr 2010 | atherosclerosis, carotid stenosis | Maastricht University Medical Center | Completed | No outcome recorded |
| — | NCT00593190 | Jan → Dec 2008 | acute hydrops keratoconus | HaEmek Medical Center, Israel | Completed | No outcome recorded |
| — | NCT00243698 | May 2004 → May 2007 | breast neoplasm | University Hospital, Tours | Completed | No outcome recorded |
| Comparator or background therapy18 trials | ||||||
| Phase 0 | NCT03296852 Background | Apr → Sep 2018 | stroke disorder | University of California, Los Angeles | Completed | No outcome recorded |
| Phase 1 | NCT06600880 Background | Aug 2027 → Jul 2028 expected | — | Columbia University | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT05569122 Background | Mar 2023 → Sep 2027 expected | pure mitochondrial myopathy | Children's Hospital of Philadelphia | Recruiting | No outcome recorded |
| Phase 1 | NCT03335020 Comparator | Apr 2018 → Dec 2020 | atherosclerosis, fibromuscular dysplasia, idiopathic spontaneous coronary artery dissection, segmental arterial mediolysis | Mayo Clinic | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT06329570 Background | Oct 2024 → Dec 2027 | glioblastoma, primary brain neoplasm | NaviFUS Corporation | Suspended | No outcome recorded |
| Phase 1/2 | NCT03477019 Background | Nov 2018 → Dec 2022 | breast neoplasm, colorectal neoplasm | St. Olavs Hospital | Completed | No outcome recorded |
| Phase 2 | NCT03458975 Comparator | Oct 2019 → Sep 2022 | metastasis from malignant tumor of colon | University Hospital, Tours | Completed | No outcome recorded |
| Phase 2 | NCT03058614 Comparator | Jun 2017 → May 2022 | nephrolithiasis | University of California, San Francisco | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT06400004 Comparator | Jul 2024 → May 2026 overdue | heart disorder | Bracco Diagnostics, Inc | Recruiting | No outcome recorded |
| Phase 3 | NCT04640038 Background | Dec 2020 → Sep 2021 | COVID-19, COVID-19–associated multisystem inflammatory syndrome in children | Children's Hospital of Philadelphia | Completed | No outcome recorded |
| Phase 3 | NCT03385200 Comparator | Dec 2016 → Jun 2019 | breast carcinoma | RWTH Aachen University | Unknown | No outcome recorded |
| Phase 3 | NCT03335566 Comparator | May 2014 → Apr 2015 | liver disorder | GE Healthcare | Completed | No outcome recorded |
| Phase 4 | NCT04569799 Background | Oct 2020 → Oct 2022 | hepatocellular carcinoma | Milton S. Hershey Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT03235180 Background | Jun 2017 → Oct 2021 | Crohn disease | Mayo Clinic | Terminated | No outcome recorded Stop: Business |
| — | NCT07274787 Background | Dec 2026 → Dec 2028 expected | glioblastoma | University of Cincinnati | Not yet recruiting | No outcome recorded |
| — | NCT02560467 Background | Dec 2015 → Sep 2019 | hypertrophic cardiomyopathy | Oregon Health and Science University | Unknown | No outcome recorded |
| — | NCT02185469 Comparator | Jul 2014 → Jun 2015 | rhegmatogenous retinal detachment | Sunnybrook Health Sciences Centre | Unknown | No outcome recorded |
| — | NCT01765036 Background | Jul 2009 → Sep 2010 | pancreatic adenocarcinoma | Société Française d'Endoscopie Digestive | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2025-08-05 | Bracco Diagnostics, Inc | Regulatory Bracco Imaging Receives Regulatory Approval in China for Sulphur hexafluoride (SF6) in the Assessment of Fallopian Tube Patency bracco.com ↗
Bracco Imaging, a global leader in diagnostic imaging, today announced that its ultrasound contrast agent has been approved by the China’s National Medical Products Administration (NMPA) for use in hysterosalpingo-contrast-sonography (HyCoSy). |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2025-08-05 | Bracco Diagnostics, Inc | Bracco Imaging Receives Regulatory Approval in China for Sulphur hexafluoride (SF6) in the Assessment of Fallopian Tube Patency bracco.com ↗ |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 64 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | LUMASON | “In 2016, the Food and Drug Administration (FDA) approved Lumason (sulfur hexafluoride lipid-type A microsphere) for characterization of focal liver lesions with CEUS in both...” NCT05025449 ↗30“Injection of Sulfur hexafluoride lipid-type A microspheres (Lumason) contrast agent will be performed via the existing peripheral intravenous line using the FDA-recommended...” NCT03549520 ↗ “Injection of Sulfur hexafluoride lipid-type A microspheres (Lumason) contrast agent will be performed via the existing peripheral intravenous line using the FDA-recommended...” NCT04640038 ↗ “Injection of Sulfur hexafluoride lipid-type A microspheres (Lumason) contrast agent will be performed via the existing peripheral intravenous line using the FDA-recommended...” NCT03549507 ↗ “Myocardial contrast echocardiography will be performed by intravenous administration of ultrasound contrast agent (Definity or Lumason) using FDA-approved dose limits.” NCT02560467 ↗ “These patients will also receive an IV contrast agent (Lumason) during the procedure, which is not part of standard of care, and is for research use only.” NCT04324294 ↗ “2 mL of Lumason will be injected as a single dose via a nephrostomy tube at the time of postoperative renal ultrasound” NCT03058614 ↗ “Continuous infusion of 8 mL of diluted Lumason® (4 mL of Lumason® diluted in 4 mL of saline) at a rate of 1.0 mL/min” NCT06400004 ↗ “Will be done using Lumason (Bracco Diagnostics, Inc) administered intravenously via slow hand infusion.” NCT03335020 ↗ “Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Intravenous Powder for Suspension [LUMASON]” NCT03061045 ↗ “Sulfur Hexafluoride Lipid Type A Microspheres 25 mg Injection Powder for Suspension [LUMASON]” NCT06693752 ↗ |
| Known as | LumasonTM | “Sulfur hexafluoride lipid-type A microspheres (LumasonTM, Bracco Inc) is an FDA-approved ultrasound contrast agent.” NCT03549507 ↗1“Sulfur hexafluoride lipid-type A microspheres (LumasonTM, Bracco Inc) is an FDA-approved ultrasound contrast agent.” NCT03549520 ↗ |
| Known as | SF6 | “Intracameral Gas SF6 (Sulfur Hexafluoride) Injection for Acute Hydrops in Keratoconus” NCT00593190 ↗2“Then, sulfur hexafluoride (SF6) will be injected in the vitreous cavity.” NCT02185469 ↗ “silicone oil versus sulfur hexafluoride (SF6) gas tamponades” PMID 32408387 ↗ May 2020 |
| Known as | Sonovue | “A bolus of 1.0ml of the ultrasound contrast agent (so called 'Microbubbles') Lumason™, internationally known as SonoVue (Bracco Pharmaceuticals, Italy), will be injected into...” NCT03296852 ↗22“One to two bolus (each 2.4mL) of SonoVue per patient in the optimization part” NCT00911027 ↗ “Gaseous microbubbles (Sonovue) combinated with Ultrasounds” NCT03458975 ↗ “contrast agent (SonoVue, Bracco, Milan, Italy)” NCT04660136 ↗ “microbubbles (MB) (SonoVue® )” NCT06496971 ↗ “Drug: Sonovue and Sonazoid” NCT04006275 ↗ |
| Known as | SonoVue (25 mg under sulfur hexafluoride gas) / Lumason | “SonoVue (25 mg under sulfur hexafluoride gas) / Lumason” NCT03473249 ↗ |
| Known as | Sulfur Hexafluoride | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00000140 ↗ |
| Known as | Sulfur Hexafluoride Lipid Type A Microspheres | “sulfur hexafluoride lipid-type A microspheres (Lumason, Bracco Diagnostics, Monroe Township, NJ)” NCT03040323 ↗ |
| Known as | sulfur hexafluoride microbubbles | “sulfur hexafluoride microbubbles” NCT00829413 ↗ |
| Known as | sulphur hexafluoride | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00677963 ↗ |
| Modality | Other / unclassified | “sulfur hexafluoride (SF6) gas tamponades” PMID 32408387 ↗ May 2020 |
| Route | Other | “intraocular long-acting gas” NCT00000140 ↗ |