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Perflutren Lipid microsphere · 1 trial · 2 indications
Lesions will be assessed for change in size, calcification, and septation using Bosniak criteria to determine whether a lesion has progressed, regressed or is stable.
| Arm | Type | Description |
|---|---|---|
| Perflutren Lipid Microsphere (Healthy subjects) | EXPERIMENTAL | Healthy subjects will be imaged using contrast-enhanced ultrasound (perflutren) for image optimization prior to enrolling clinical patients. |
| Perflutren Lipid Microsphere (patients with kidney lesions) | EXPERIMENTAL | Patients with kidney lesions will be imaged using contrast-enhanced ultrasound with perflutren. |
| Controls: No interaction | NO_INTERVENTION | Patients with kidney lesions will be included as control subjects. These patients will be followed, but will not receive any study intervention. |
| Name | Type | Description |
|---|---|---|
| Perflutren Lipid microsphere | DRUG | Perflutren will be administered in a bolus or continuous infusion using the dosing range and administration type within the perflutren prescribing information.Once perflutren lipid has been administered, the transducer is maintained in a constant position over the area of interest to show the target lesion in order to assess the enhancement pattern during the early, mid and late vascular phases. Images will also be taken of kidney parenchyma in a suitable longitudinal plane.If there are multiple lesions in one subject requiring a second dose, the subject will have the option to undergo a 2nd contrast-enhanced study 30-minutes after the initial contrast dose, per dosing instructions in the package insert. |
Inclusion Criteria: To be eligible for the present study, patients must meet the following criteria: 1. Able to provide written informed consent 2. Willing to comply with protocol requirements 3. At least 18 years of age 4. Have kidney disease, defined as either chronic kidney disease (CKD) II-V, ...
Perflutren Lipid microsphere is an investigational agent being studied for use in chronic kidney disease. It is being evaluated as a contrast-enhanced ultrasound agent for the diagnosis of complex kidney lesions in patients with chronic kidney disease and cystic kidney disease. The drug is in Phase 2 clinical development.
Perflutren Lipid microsphere is a small molecule that acts as an ultrasound contrast agent. It is used to enhance ultrasound imaging, allowing for better visualization of complex kidney lesions in patients with chronic kidney disease. The drug does not target a specific molecular receptor but rather improves imaging contrast.
Perflutren Lipid microsphere is being developed by Lantheus Holdings, Inc., a company traded on the NASDAQ under the ticker symbol LNTH. The company is conducting clinical research to evaluate the drug's potential in diagnosing kidney lesions in patients with chronic kidney disease.
Perflutren Lipid microsphere is in Phase 2 clinical development. It is an investigational agent and has not been approved by regulatory authorities. The drug is being studied for its use in contrast-enhanced ultrasound to diagnose complex kidney lesions in patients with chronic kidney disease.
Perflutren Lipid microsphere has one completed Phase 2 clinical trial, identified as NCT03196076. This trial, titled "Contrast-enhanced Ultrasound for Complex Kidney Lesion Diagnosis in Patients With CKD Extension," enrolled 25 participants in the United States. The study was not randomized or double-blinded and had no treatment control.