Contrast Media and CT Image Reconstruction from GE Healthcare Medical Diagnostics Set New Standard for Quality Imaging and Patient Care

Today, GE Healthcare’s Medical Diagnostics business (MDx) announced results of a pivotal study outlining the potential to use lower iodine concentration and reduced radiation exposure in an abdominal CT scanning procedure. The study showed that advanced CT reconstruction techniques such as ASiR^TM or Veo^TM, combined with the isosmolar contrast agent, Visipaque^TM (270 or 320mgI/ml) and low kVp, deliver equivalent or better contrast enhancement and improved diagnostic images when compared to iomeprol (400mgI/ml) injected at the same volume and rate (2ml/kg at 3,5ml/sec). By lowering both the radiation and iodine dose, the image quality was not compromised, thus ensuring confident diagnosis. The results of this study carried out by Dr. Jean-Louis Sablayrolles, Chief of the CT and MRI Department, Centre Cardiologique du Nord, St. Denis, France, were presented at the European Congress of Radiology (ECR) 2012 on Sunday 4^th March, 2012.

High iodine concentration and dose, in addition to the radiation exposure associated with the use of contrast-enhanced (CE) CT scans, can be a concern for radiologists in patients more susceptible to cardio-renal complications after CE CT and for those CT scanned more regularly.^1,2 Dr Sablayrolles said that, "these types of protocols with low energy CT techniques which use a lower concentration of contrast could potentially help physicians in the future, enabling them to reduce both radiation exposure and the risk of cardio-renal related events, particularly in the more vulnerable population. Such improved contrast enhancement at low iodine concentration and/or lower radiation dose represents a clear opportunity to improve patient care in CT.”

"The ability to reduce iodine concentration and radiation with our low dose CT technologies and isosmolar contrast agent, Visipaque, is just one of the many promising improvements for radiology patients. GE Healthcare is committed to continuing research in lowering iodine concentration in contrast media and radiation dose to improve patient care during diagnosis and treatment,” said Clemens Kaiser, General Manager, Contrast Media, GE Healthcare, and Medical Diagnostics.

About the Study

Dr Sablayrolles’ study examined patients who underwent abdominal CT scans (at 80, 100 or 120 kVp) after the injection of Visipaque (270 or 320 mgI/ml, 2ml/kg at 3.5 ml/sec ) or iomeprol (400 mgI/ml, 2ml/kg at 3.5 ml/s). CT scans were performed at 80, 100 and 120kVp to obtain arterial phase (25-35s) and portal phase (65-75s) data, and acquisition parameters were set according to the patient’s body mass index (BMI). In both settings, projection data was reconstructed with filter back projection (FBP) and two types of iterative reconstruction (ASIR-50 percent and Veo).³

Researchers found that a reduction in kVp levels combined with noise reduction software such as ASiR and Veo, to counteract increased image noise, enabled both iodine concentration and radiation exposure to be reduced. Specifically, contrast enhancement with iomeprol 400mgI/ml was not superior to Visipaque 320mgI/ml when used in conjunction with ASiR and Veo. These reconstructions using ASiR and Veo improved overall image quality of parenchyma, edges and interfaces and vascular structures.³

About the Discovery CT750HD

Introduced in 2008 as the world’s first high definition CT system, the Discovery CT750 HD is powered by GE’s exclusive HD and low dose technologies, including GSI for lesion characterization, proven ASiR dose-optimizing technology already used on over 10 million scans at 1,000 sites across the globe, and Veo, GE’s second generation model-based iterative reconstruction technique. Veo, currently available on the Discovery CT750 HD, opens the door to high image performance at previously unheard of CT low-dose levels. With sub-millisievert capabilities that help physicians deliver confident diagnosis, Veo potentially enables lower noise, improved low contrast detectability and spatial resolution, and fewer low signal artifacts.

ABOUT GE HEALTHCARE

GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our broad expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, drug discovery, biopharmaceutical manufacturing technologies, performance improvement and performance solutions services help our customers to deliver better care to more people around the world at a lower cost. In addition, we partner with healthcare leaders, striving to leverage the global policy change necessary to implement a successful shift to sustainable healthcare systems.

Our "healthymagination” vision for the future invites the world to join us on our journey as we continuously develop innovations focused on reducing costs, increasing access and improving quality and efficiency around the world. Headquartered in the United Kingdom, GE Healthcare is a unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employs more than 46,000 people committed to serving healthcare professionals and their patients in more than 100 countries. For more information about GE Healthcare, visit our web site at www.gehealthcare.com.

The content of the press release is not cleared by US FDA

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¹ Gurm HS et al. Renal Function-Based Contrast Dosing to Define Safe Limits of Radiographic Contrast Media in Patients Undergoing Percutaneous Coronary Interventions. Journal of American College of Cardiology, 58: 907-14.

² Scanlon PJ et al. ACC/AHA Guidelines for Coronary Angiography. Journal of American College of Cardiology 33: 1756-1824.

³ Sablayrolles, Jean-Louis. Preserving Diagnostic Image Quality with Advanced CT Image Reconstruction and Low Concentration Iso-osmolar Visipaque^TM. European Congress of Radiology 2012.

VISIPAQUE

Int’l English prescribing information

PRESCRIBING INFORMATION VISIPAQUE™ iodixanol

Indications and approvals may vary in different countries. Please refer to the local Summary of Product Characteristics [SPC] before prescribing. Further information available on request.

PRESENTATION

An isotonic, aqueous solution containing iodixanol, a non-ionic, dimeric contrast medium, available in two strengths containing either 270 mg or 320 mg iodine per ml.

INDICATIONS

This medicinal product is for diagnostic use only. X-ray contrast medium for cardioangiography, cerebral angiography, peripheral arteriography, abdominal angiography, urography, venography, CT enhancement. Lumbar, thoracic and cervical myelography. Arthrography, hysterosalpingography (HSG) and studies of the gastrointestinal tract.

DOSAGE AND ADMINISTRATION

Adults and children: Dosage varies depending on the type of examination, age, weight, cardiac output, general condition of patient and the technique used (see SPC and package leaflet).

CONTRA-INDICATIONS

Hypersensitivity to the active substance or to any of the excipients. Manifest thyrotoxicosis. History of serious hypersensitivity reaction to Visipaque.

PRECAUTIONS, WARNINGS, ETC

A positive history of allergy, asthma, or reaction to iodinated contrast media indicates need for special caution. Premedication with corticosteroids or H1 and H2 antagonists should be considered in these cases. Although the risk of serious reactions with Visipaque is regarded as low, iodinated contrast media may provoke serious, life-threatening, fatal anaphylactic/ anaphylactoid reactions or other manifestations of hypersensitivity. Therefore the necessary drugs and equipment must be available for immediate treatment. Patients should be observed for at least 30 minutes following administration of contrast medium, however delayed reactions may occur. Non-ionic contrast media have less effect on the coagulation system in vitro, compared to ionic contrast media. When performing vascular catheterization procedures one should pay meticulous attention to the angiographic technique and flush the catheter frequently (eg. with heparinised saline) so as to minimize the risk of procedure-related thrombosis and embolism. Ensure adequate hydration before and after examination especially in patients with renal dysfunction, diabetes mellitus, paraproteinemias, the elderly, children and infants or after major surgery. Special care should also be taken in patients with hyperthyroidism, serious cardiac disease, pulmonary hypertension, patients predisposed to seizures (acute cerebral pathology, tumours, epilepsy, alcoholics and drug addicts), and patients with myasthenia gravis or phaeochromocytoma. Particular care is required in patients with severe disturbance of both renal and hepatic function as they may have significantly delayed contrast medium clearance. All iodinated contrast media may interfere with laboratory tests for thyroid function, bilirubin, proteins, or inorganic substances (e.g. iron, copper, calcium, and phosphate). To prevent lactic acidosis, serum creatinine level should be measured in diabetic patients treated with metformin prior to intravascular administration of iodinated contrast medium. Normal serum creatinine/renal function: Administration of metformin should be stopped at the time of administration of contrast medium and not resumed for 48 hours or until renal function/serum creatinine is normal. The timing of this should be amended based upon serum creatinine/renal function levels. (Refer to SPC). An increased risk of delayed reactions (flu-like or skin reactions) has been associated with patients treated with interleukin-2 up to two weeks previously. Following myelography the patient should remain in a supine position with head up for a while and should not be left alone for 12 to 24 hours. The safety of Visipaque in pregnancy has not been established. Breast feeding may be continued after administration of the product.

UNDESIRABLE EFFECTS

Undesirable effects associated with VISIPAQUE are usually mild to moderate and transient in nature. Serious reactions as well as fatalities are only seen on very rare occasions. Hypersensitivity reactions may present as respiratory or cutaneous symptoms like dyspnoea, rash, erythema, urticaria, pruritus, severe skin reactions, angioneurotic oedema, hypotension, fever, laryngeal oedema, bronchospasm or pulmonary oedema. They may appear either immediately after the injection or up to a few days later. Hypersensitivity reactions may occur irrespectively of the dose and mode of administration and mild symptoms may represent the first signs of a serious anaphylactoid reaction/shock. Administration of the contrast medium must be discontinued immediately and, if necessary, specific therapy instituted via the vascular access. Patients using beta blockers may present with atypical symptoms of hypersensitivity which may be misinterpreted as a vagal reaction. Neurological reactions, headache, dizziness, seizures, and transient motor or sensory disturbance (e.g. taste or smell alteration, transient blindness) may occur. Severe respiratory symptoms and signs (including dyspnoea and non-cardiogenic pulmonary oedema), and cough may occur.Also reported are; vagal reactions, cardiac arrhythmia, depressed cardiac function, ischaemia, hypertension and iodism. Arterial spasm may follow injection. A minor transient rise in creatinine is common. Renal failure is very rare. Post phlebographic phlebitis or thrombosis is very rare. Arthralgia is very rare.

Intrathecal use: Headache, nausea, vomiting or dizziness. Mild local pain and pain at the site of injection may occur.

Meningeal irritation giving photophobia and meningism and frank chemical meningitis have been observed with other non-ionic iodinated contrast media. The possibility of an infective meningitis should also be considered.

Oral use: diarrhoea, nausea, vomiting, abdominal pain.

Hysterosalpingography (HSG): Transient pain in the lower abdomen. Vaginal bleeding/discharge, nausea, vomiting, headache, fever.

Arthrography: Pressure sensation and post procedural pain.

In patients with autoimmune diseases cases of vasculitis and SJS-like syndrome were observed.

OVERDOSE

In the unlikely event of accidental overdosing, renal function should be monitored for at least 3 days in addition to supportive measures. Haemodialysis should be considered if needed.

MARKETING AUTHORISATION HOLDER

GE Healthcare AS, Nycoveien 1-2, Postboks 4220 Nydalen, NO-0401 Oslo, Norway.

CLASSIFICATION FOR SUPPLY

Subject to medical prescription (POM).

DATE OF PREPARATION

31 March 2011.