OMNISCAN SUMMARY
OMNISCAN (gadodiamide) Injection is the formulation of the gadolinium complex of diethylenetriamine pentaacetic acid bismethylamide, and is an injectable, nonionic extracellular enhancing agent for magnetic resonance imaging. OMNISCAN is to be administered by intravenous injection. OMNISCAN is provided as a sterile, clear, colorless to slightly yellow, aqueous solution. Each mL contains 287 mg gadodiamide, 12 mg caldiamide sodium and water for injection. The pH is adjusted between 5.5 and 7.0 with hydrochloric acid and/or sodium hydroxide. OMNISCAN contains no antimicrobial preservative. OMNISCAN is a 0.
CNS (Central Nervous System)
OMNISCAN is indicated for intravenous use in MRI to visualize lesions with abnormal vascularity (or those thought to cause abnormalities in the blood-brain barrier) in the brain (intracranial lesions), spine, and associated tissues.
Body (Intrathoracic [noncardiac], Intra-abdominal, Pelvic and Retroperitoneal Regions)
OMNISCAN is indicated for intravenous administration to facilitate the visualization of lesions with abnormal vascularity within the thoracic (noncardiac), abdominal, pelvic cavities, and the retroperitoneal space.
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NEWS HIGHLIGHTSMedia Articles Related to Omniscan (Gadodiamide)
The Diagnostic Clinic Introduces A Vaccination Alternative To The Flu Jab
Source: Flu / Cold / SARS News From Medical News Today [2009.11.12]
The Diagnostic Clinic in London's New Cavendish Street, the UK's premier centre for Integrated Medicine, offers a vaccination alternative for private and corporate patients not wishing to have the Flu or Swine Flu jab. Many people have concerns regarding vaccinations. Whether this is as simple as needle phobia or concerns over the safety of vaccinations, an alternative can be considered.
Phadia Introduces New Food Allergy Diagnostic Tools To Meet The Needs Of Allergists
Source: Allergy News From Medical News Today [2009.11.10]
Today at the 2009 Annual Meeting of the American College of Allergy, Asthma & Immunology, Phadia US introduced two new products designed specifically to meet the unique needs of the nation's 6,000 allergists. ImmunoCAP ISAC and ImmunoCAP HR are new offerings designed to augment traditional allergy testing methodologies and enable diagnosis of complex food allergies at the molecular level, available through its own PiRL testing facility.
New Diagnostic Method For Gout: Dual Energy Computed Tomography Instead Of Joint Aspiration
Source: Gout News From Medical News Today [2009.06.05]
The most reliable method of diagnosing gout is to aspirate the joint in order to obtain fluid to verify the presence of monosodiumurate crystals (uric acid). Up to now, computed tomography (CT) has played a limited role in the evaluation of gout, since conventional CT systems cannot reliably verify deposits of uric acid.
Utility Of Circulating DNA As Novel Diagnostics For Human Cancer, Mad Cow Disease And Other Conditions
Source: CJD / vCJD / Mad Cow Disease News From Medical News Today [2009.03.12]
Chronix Biomedical - developing and applying proprietary techniques to detect and analyze circulating nucleic acid sequences for the diagnosis and management of disease - reported that three recent studies published in peer-reviewed journals have further confirmed the potential diagnostic and prognostic utility of fragments of DNA and RNA that circulate in the blood, known as circulating nucleic acids (CNAs).
Diagnostic Approved to Detect
Source: MedicineNet Clostridium Difficile Colitis Specialty [2009.01.14]
Title: Diagnostic Approved to Detect
Category: Health News
Created: 1/14/2009 2:00:00 AM
Last Editorial Review: 1/14/2009
Published Studies Related to Omniscan (Gadodiamide)
Abdominal and iliac arterial stenoses: comparative double-blinded randomized study of diagnostic accuracy of 3D MR angiography with gadodiamide or gadopentetate dimeglumine. [2006.03]
PURPOSE: To prospectively evaluate accuracy of gadolinium-enhanced three-dimensional (3D) magnetic resonance (MR) angiography with gadodiamide and gadopentetate dimeglumine (0.1 mmol/kg), with intraarterial DSA as reference standard, for imaging abdominal and iliac arterial stenoses... CONCLUSION: Noninferiority of gadodiamide versus gadopentetate was verified based on the primary end point, which was accuracy for detection of the main stenosis with enhanced 3D MR angiography compared with DSA. Copyright RSNA, 2006.
Contrast-enhanced magnetic resonance angiography of the lower extremities: standard-dose vs. high-dose gadodiamide injection. [2005.04]
PURPOSE: To compare the efficacy and safety of two different doses (0.1 and 0.3 mmol/kg of body weight [BW]) of gadodiamide for contrast-enhanced magnetic resonance angiography (ce-MRA) of the lower extremities with intraarterial digital subtraction angiography (IA-DSA)... CONCLUSION: Ce-MRA with gadodiamide is safe and efficacious. Comparison of two different doses with IA-DSA as the standard of reference showed that the 0.3 mmol/kg dose is superior to the standard 0.1 mmol/kg dose with respect to contrast enhancement, vessel delineation, image quality, and detection of collaterals. However, the 0.1 mmol/kg dose was superior to the high dose in the grading of stenosis. Copyright 2005 Wiley-Liss, Inc.
MR characterization of mild hyperthermia-induced gadodiamide release from thermosensitive liposomes in solid tumors. [2008.12]
CONCLUSION: HT-induced CA release from Gd-TSL was monitored and characterized by MRI after i.v. injection in tumor-bearing mice. Higher temperatures resulted in higher signal changes. Immediately after i.v. injection, heated tumor tissue was distinguishable from unheated tumor tissue. The Gd-TSL appears to be suitable for MR monitoring of HT tumor treatment in a clinical MRI setting independent of field strength.
Contrast-enhanced MR imaging of brain lesions: a large-scale intraindividual crossover comparison of gadobenate dimeglumine versus gadodiamide. [2008.10]
BACKGROUND AND PURPOSE: The higher relaxivity of gadobenate dimeglumine compared with gadodiamide is potentially advantageous for contrast-enhanced brain MR imaging. This study intraindividually compared 0.1-mmol/kg doses of these agents for qualitative and quantitative lesion enhancement... CONCLUSION: Significantly greater diagnostic information and lesion enhancement are achieved on brain MR imaging with 0.1-mmol/kg gadobenate dimeglumine compared with gadodiamide at an equivalent dose.
MR diskography and CT diskography with gadodiamide-iodinated contrast mixture for the diagnosis of foraminal impingement. [2008.09]
CONCLUSION: Simultaneous MR diskography and CT diskography with a mixture of gadodiamide and iodinated contrast material may be beneficial for evaluating foraminal impingement causing lumbar radiculopathy.
Clinical Trials Related to Omniscan (Gadodiamide)
Post-marketing Safety Study in Patients With Moderate Renal Insufficiency Who Receive Omniscan for Contrast-enhanced Magnetic Resonance Imaging (MRI) [Recruiting]
This will be an international, multi-center, post-marketing surveillance study in patients
with moderate renal insufficiency who are administered gadodiamide, Omniscan, during a MRI.
Omniscan will be administered intravenously at the medical discretion of the prescribing
physician.
A Safety & Efficacy Clinical Study to Evaluate the Narrowing of the Renal Arteries While Using Gadodiamide [Completed]
Magnetic Resonance Angiography (MRA) is an examination similar to Magnetic Resonance Imaging
(MRI) which uses a magnetic field and a contrast medium when needed to visualize blood flow
in the arterial vessels throughout the body.
Gadodiamide, a contrast medium, is already approved and is used to image blood vessels by
directly injecting it into the vein, but this procedure has not been formally tested to image
the renal artery vessels using MR.
The study is designed to determine the presence or absence of a relevant stenosis (ie greater
than/equal to 50%) or occlusion in renal arteries. Intra-arterial Digital Subtraction
Angiography will be used as the standard of truth.
A Safety and Efficacy Clinical Study to Evaluate the Narrowing of the Aorto-Iliac Arteries While Using Gadodiamide [Completed]
Magnetic Resonance Angiography (MRA) is an examination similar to Magnetic Resonance Imaging
(MRI) which uses a magnetic field and a contrast medium when needed to visualize blood flow
in the arterial vessels throughout the body.
Gadodiamide, a contrast medium, is already approved and is used to image blood vessels by
directly injecting it into the vein, but this procedure has not been formally tested to image
the aorto-iliac vessels using MR.
The study is designed to determine the presence or absence of a relevant stenosis (ie greater
than/equal to 50%) or occlusion in aorto-iliac arteries. Intra-arterial Digital Subtraction
Angiography (IADSA) will be used as the standard of truth.
A Study Comparing Two Magnetic Resonance Imaging (MRI) Contrast Agents in MRI of the Brain [Completed]
This study aims at a direct comparison between Multihance and a validated comparator like
Omniscan in a cross-over individual design in patients with brain tumors to confirm the
superior overall diagnostic performance of MuliHance for this indication
Early Detection of Glioblastoma Multiforme (GBM) Treatment Responses Using Multiple Magnetic Resonance Modalities [Recruiting]
The purpose of this study is to determine whether dynamic contrast enhanced MRI (DCE MRI)
and high diffusion weighting MRI may be used to distinguish between favorable and
unfavorable responses to therapy of glioblastoma multiforme. Imaging data will be
correlated with histopathologic findings and clinical responses to radiation therapy with or
without chemotherapy.
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