News | June 24, 2007

Molecular Insight Pharmaceuticals, Inc. Initiates Trial for Zemiva in Detection of Cardiac Ischemia

June 25, 2007 — Molecular Insight Pharmaceuticals, Inc. announced today that it has initiated a Phase 2 trial with Zemiva (iodofiltic acid I 123 or BMIPP) for the diagnosis of cardiac ischemia, or lack of sufficient blood supply to an area of the heart, in patients with suspected Acute Coronary Syndrome (ACS) in the emergency department setting.

Zemiva is a metabolic, molecular imaging pharmaceutical that has previously demonstrated the ability to detect cardiac ischemia up to 30 hours after an ischemic event as compared to currently available techniques, which are limited to an approximate two hour imaging window.

The current trial, which is expected to involve an estimated 600 to 700 patients at up to 70 centers in the United States and Canada, is designed to be a pivotal registration trial that, upon replication in a successive confirmatory Phase 3 trial, could form the basis of an application with the U.S. Food and Drug Administration (FDA) for marketing approval. Molecular Insight expects to report top line data from this trial in the second half of 2008.

For more information: www.molecularinsight.com

Related Content

Study Finds No Evidence that Gadolinium Causes Neurologic Harm

MR images through, A, C, E, basal ganglia and, B, D, F, posterior fossa at level of dentate nucleus. Images are shown for, A, B, control group patient 4, and the, C, D, first and, E, F, last examinations performed in contrast group patient 13. Regions of interest used in quantification of signal intensity are shown as dashed lines for globus pallidus (green), thalamus (blue), dentate nucleus (yellow), and pons (red).

News | Contrast Media | January 11, 2018
January 11, 2018 — There is no evidence that accumulation in the brain of the element gadolinium speeds cognitive dec
Male Triathletes May Be Putting Their Heart Health at Risk
News | Cardiac Imaging | January 09, 2018
Competitive male triathletes face a higher risk of a potentially harmful heart condition called myocardial fibrosis,...
Videos | Magnetic Resonance Imaging (MRI) | December 19, 2017
Emanuel Kanal, M.D., director of MRI services and professor of radiology and neuroradiology at the University of Pitt
The FDA issued new warnings on MRI gadolinium contrast agents. (GBCAs)

The FDA issued new warnings on MRI gadolinium contrast agents. 

Feature | Magnetic Resonance Imaging (MRI) | December 19, 2017
The U.S.
Brainlab Contrast Clearance Analysis Software Receives FDA 510(k) Clearance
Technology | Contrast Media | December 12, 2017
Brainlab announced U.S. Food and Drug Administration (FDA) clearance of its Contrast Clearance Analysis methodology,...
Sectra Offers Gadolinium Tracking Functionality in DoseTrack Software
Technology | Contrast Media | December 11, 2017
December 11, 2017 — Sectra recently announced the global introduction of gadolinium tracking in its dose monitoring s
Videos | Magnetic Resonance Imaging (MRI) | December 07, 2017
Max Wintermark, M.D., professor of radiology and chief of neuroradiology, Stanford Hospital and Clinics, discussed MR
Guerbet to Participate in French Interventional Radiology Conference
News | Contrast Media | October 10, 2017
Guerbet announced it will be taking part in the 65th edition of the Journées Francophones de Radiologie (JFR) that will...
Trends in contrast media used in magnetic resonance imaging and computed tomography

Image courtesy of Bayer

Feature | Contrast Media | October 04, 2017 | By Dave Fornell
Over the past decade, several clinical studies have shown gadolinium-based magnetic resonance imaging (MRI) contrast...
Overlay Init