15 completed, 8 recruiting, 5 terminated, 4 withdrawn. 10 Phase 1, 10 Phase 2, 6 Phase 4, 5 Early Phase 1, 4 Phase 3.
Follow Lumason: new trials by email Literature Review of Lumason trials Research Report on Lumason
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Neuronavigation-guided FUS-induced BBB Opening in Alzheimer's Disease Patients and Its Effects on Brain Amyloid and Tau Neuronavigation-guided single-element focused ultrasound transducer, Lumason, Magnetic Resonance Imaging (MRI) with or without gadolinium contrast agents - Alzheimer Disease, Early Onset | Phase 1 | Not yet recruiting | Columbia University | 6 | 2027-08-01 | 2026-05-13 |
| Radiation-Free Technique for Evaluating Renal Scarring (RAFTERS) Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON] - Vesico-Ureteral Reflux | Phase 1 | Not yet recruiting | Boston Children's Hospital | 70 | 2027-07-01 | 2026-07-22 |
| Safety And Effectiveness Of NaviFUS System With Bevacizumab In Recurrent Glioblastoma NaviFUS System, Lumason, Bevacizumab - GBM | Not applicable | Not yet recruiting | University of Cincinnati | 10 | 2026-12-01 | 2026-06-04 |
| NgFUS NIVO: NeuroNavigation-Guided Focused Ultrasound With Nivolumab in Relapsed and Progressive DMG and Other High Grade Brain Tumors NeuroNavigation-Guided Focused Ultrasound (NgFUS), Lumason, Nivolumab - Diffuse Midline Glioma or Diffuse Intrinsic Pontine Glioma, High Grade Gliomas | Phase 1 | Recruiting | Children's National Research Institute | 30 | 2026-09-01 | 2026-09-09 |
| Y-90 Treatment Response Using Transarterial Radioembolization Lumason, Sonazoid - HCC, Hepatocellular Carcinoma | Phase 2 | Recruiting | Thomas Jefferson University | 30 | 2025-09-11 | 2026-06-10 |
| Safety and Efficacy of Bevacizumab in Combination With NaviFUS System for the Treatment of Recurrent Glioblastoma Multiforme (rGBM) NaviFUS System, Lumason, Bevacizumab - Glioblastoma Multiforme, Glioblastoma | Phase 1 / Phase 2 | Suspended | NaviFUS Corporation | 10 | 2024-10-22 | 2026-09-09 |
| Contrast Enhanced Ultrasound to Evaluate Response to Chemoembolization in Patients With Liver Tumors Sulfur Hexafluoride Lipid Microspheres, Contrast-Enhanced Ultrasound, Transarterial Chemoembolization - Liver Neoplasms | Phase 2 | Recruiting | john eisenbrey | 266 | 2024-08-07 | 2026-02-17 |
| Lumason® Infusion vs. Bolus Administrations Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON], Lumason - Heart Diseases | Phase 3 | Recruiting | Bracco Diagnostics, Inc | 106 | 2024-07-10 | 2026-10-20 |
| Pilot Study to Evaluate if Contrast Enhanced Ultrasound (CEUS) Can Predict Treatment Response in Triple Negative Breast Cancer (TNBC) Patients Receiving Combined Chemotherapy and Immune Checkpoint Inhibitors (ICI). Lumason - Breast Cancer, Contrast Enhanced Ultrasound | Early Phase 1 | Withdrawn | Milton S. Hershey Medical Center | 2023-09-01 | 2025-12-10 | |
| Contrast-Enhanced Ultrasound and Shear Wave Elastography for the Treatment of Lymphedema Lumason, Optison, Definity - Lymphedema Arm | Phase 1 | Completed | Mayo Clinic | 10 | 2022-12-15 | 2024-08-21 |
| Contrast-Enhanced Ultrasound Imaging for Diagnosing Recurrent Renal Cell Carcinoma (RCC) Post Ablation Sulfur Hexafluoride Lipid Microspheres, Contrast-Enhanced Ultrasound, Computed Tomography - Recurrent Renal Cell Carcinoma, Renal Cell Carcinoma | Phase 2 | Recruiting | john eisenbrey | 210 | 2022-11-03 | 2026-02-17 |
| BEFAST (Bubble-Enhanced FAST) for the Evaluation of Solid Organ Injury Focused Assessment with Sonography for Trauma (FAST), Bubble-Enhanced FAST (BEFAST) - Abdominal Trauma | Phase 4 | Completed | Emory University | 267 | 2021-09-30 | 2024-10-08 |
| Contrast Ultrasound for Pediatric Trauma - Comparative Evaluation (CAPTURE Study) Lumason - Abdominal Injury | Phase 1 / Phase 2 | Completed | David Mooney | 68 | 2021-05-10 | 2025-10-03 |
| Contrast Enhanced Ultrasound Medical Imaging for Identifying Breast Masses Contrast-Enhanced Ultrasound, Perflutren Lipid Microspheres, Sulfur Hexafluoride Lipid Microspheres - Breast Carcinoma | Phase 1 | Recruiting | University of Southern California | 100 | 2020-11-05 | 2026-02-02 |
| Accuracy of Contrast-Enhanced Ultrasound for Hepatocellular Carcinoma Post TACE Lumason - Hepatocellular Carcinoma | Phase 4 | Completed | Milton S. Hershey Medical Center | 26 | 2020-10-14 | 2023-11-02 |
| Contrast-Enhanced Ultrasound for Kidney Cancer Subtyping and Staging Perflutren lipid microsphere, Sulfur hexafluoride lipid microspheres - Kidney Cancer | Phase 2 | Completed | UNC Lineberger Comprehensive Cancer Center | 25 | 2020-10-07 | 2023-11-13 |
| Contrast-Enhanced Ultrasound Diagnosis of Acute Appendicitis Sulfur hexafluoride lipid-type A microspheres - Appendicitis Acute | Phase 1 | Withdrawn | Boston Children's Hospital | 2020-07-15 | 2020-07-17 | |
| Contrast Enhanced Ultrasound in Human Crohn's Disease-Lumason Ultrasound Microbubble Contrast Agent, Ultrasound Imaging - Crohn Disease | Completed | Children's Hospital Medical Center, Cincinnati | 25 | 2020-03-06 | 2026-06-15 | |
| Comparison of Three Methods for Early Detection of Breast Cancer Contrast Enhanced imaging, Lumason - Proliferative Breast Disease | Early Phase 1 | Completed | Mayo Clinic | 3 | 2019-10-15 | 2022-01-10 |
| Contrast-enhanced Ultrasound as a Screening Tool for Kidney Cancer in Patients With Von-Hippel Lindau Perflutren lipid microsphere, Sulfur hexafluoride lipid microspheres - Von-Hippel Lindau, Kidney Disease, Chronic | Phase 2 | Completed | UNC Lineberger Comprehensive Cancer Center | 15 | 2019-09-23 | 2024-05-21 |
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Abdominal Injuries (4) · Carcinoma, Hepatocellular (3) · Appendicitis (2) · Brain Neoplasms (2) · Breast Neoplasms (2) · Coronary Artery Disease (2) · Crohn Disease (2) · Glioma (2) · Heart Diseases (2) · Liver Neoplasms (2) · Alzheimer Disease (1) · Carcinoma (1) · Carcinoma, Renal Cell (1) · Carotid Stenosis (1) · Constriction, Pathologic (1)
Mayo Clinic (5) · Bracco Diagnostics, Inc (4) · Boston Children's Hospital (2) · Children's Hospital of Philadelphia (2) · David Mooney (2) · Indiana University (2) · Milton S. Hershey Medical Center (2) · UNC Lineberger Comprehensive Cancer Center (2) · University of Southern California (2) · john eisenbrey (2) · Children's Hospital Medical Center, Cincinnati (1) · Children's Mercy Hospital Kansas City (1) · Children's National Research Institute (1) · Columbia University (1) · Emory University (1)
United States (36) · Canada (2) · Belgium (1) · Germany (1) · Italy (1) · United Kingdom (1)
David Mooney, MD, MPH (2) · Emily Chang, MD (2) · Matthew W Urban (2) · Melda Dolan, MD (2) · Aaron E Chen, MD (1) · Bino A Varghese, PhD (1) · Christine Lee, MD, PhD (1) · David S Liebeskind, MD (1) · Grace McIlvain, PhD (1) · Harriet Paltiel, MDCM (1) · Harshawn Malhi, MD (1) · John Eisenbrey, PhD (1) · Jonathan Dillman, MD,MSc (1) · Jordan K Swennson, MD (1) · Jose Banchs, MD (1)
PMID 34783716, PMID 35399083, PMID 39589314
P30CA014089 (2), P30CA016672 (1), R01CA194307 (1), R01CA195524 (1), R01CA269750 (1), R21CA303648 (1)