Perfluorobutane

Overview

Perflubutane has been used in trials studying the diagnostic of Liver Mass, Liver Diseases, Liver Metastasis, Portal Hypertension, and Peripheral Artery Disease. It is a cardiovascular drug designed to enable ultrasound to compete more effectively with nuclear stress testing; currently the leading procedure for detecting coronary heart disease.

Indication

适用于肝脏肿块病变的超声显影。

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Gynecological Sentinel Lymph Nodes CEUS	2021/11/03	NCT05105087	Early Phase 1	Completed	Thomas Jefferson University
Role of Perfluorobutane in Lesion Detection, Targeting and Response Assessment for Ablation of HCC	2021/10/05	NCT05068076	Not Applicable	Completed	Institute of Liver and Biliary Sciences, India
A Prospective Multi-center Study on Using Sonazoid Diagnose Early Stage Endometrial Cancer	2021/07/14	NCT04961775	N/A	UNKNOWN	Chinese PLA General Hospital
Comparing SonoVue With Sonazoid Using CEUS-LIRADS in HCC	2019/07/05	NCT04006275	Phase 3	UNKNOWN	Second Affiliated Hospital, School of Medicine, Zhejiang University
Contrast-Enhanced Ultrasound Identification of Sentinel Nodes in Esophageal Cancer	2018/07/06	NCT03578224	Early Phase 1	Completed	Sidney Kimmel Cancer Center at Thomas Jefferson University
Noninvasive Real-time Intracardiac Pressure Measurements Using Subharmonic Ultrasound	2017/08/10	NCT03245255	Phase 2	Completed	Thomas Jefferson University
Ischemic Memory Imaging With Myocardial Contrast Echocardiography	2017/01/04	NCT03009266	Early Phase 1	UNKNOWN	Oregon Health and Science University
Sonazoid-Enhanced Ultrasound in Detecting Sentinel Lymph Node in Patients With Cutaneous Melanoma	2016/11/18	NCT02968680	Phase 1	Terminated	University of Southern California
Superb Microvascular Imaging in Focal Nodular Hyperplasia	2016/04/14	NCT02737865	Not Applicable	Completed	Samsung Medical Center
Contrast Enhanced Ultrasonography to Detect Human Renal Transplant Rejection	2016/04/11	NCT02733029	Phase 2	Completed	Brigham and Women's Hospital

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
SONAZOID POWDER AND SOLVENT FOR DISPERSION FOR INJECTION 16 MICROLITRE PER VIAL	GE Healthcare AS (Oslo Site), B. Braun Melsungen AG (Solvent)	SIN16077P	INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION	16 μL	1/6/2021

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
Perfluorobutane Microspheres for Injection	GE Healthcare AS	国药准字HJ20201000	化学药品	注射剂	6/12/2023
Perfluorobutane Microspheres for Injection	GE Healthcare AS	国药准字HJ20180046	化学药品	注射剂	6/12/2023

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

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