The Facts About Gadolinium and NSF/NFDb

At every turn there are aggressive lawyers vying for clients who have had an MRI study with Gadolinium, and class action suits against pharmaceutical companies abound.  You may have seen it on TV or read about it in the newspaper.  There is no denying, these claims are frightening, but while some of what the legal community brings forth is valid, recognize that some of it is deceptive scare tactics.  

DIA believes in educating our referrals and patients, and guarantees to report the facts.  Our main focus at DIA is patient safety, and we have established guidelines surrounding this issue that are based on objective fact, not speculation.  DIA proceedbs with extreme caution when considering gadolinium-enhanced MRI/MRbA in renal cases, and has adopted comprehensive processes, modified protocols,b and risk management strategies for performing these diagnostic studies. 

The FDA affirms that only patients who have severe renal insufficiency appear to be at increased risk for developing the disease.  While the FDA continues to investigate reports of Nephrogenic Systemic Fibrosis (NSF), also known as Nephrogenic Fibrosing Dermopathy (NFD), in patients who received gadolinium-based contrast agents (GBCAs) to help define risk factors for NSF/NFD, it has requested the manufacturers of all five GBCAs (MAGNEVIST^®, MultiHance^®, Omniscan^ä, OptiMARK^® and ProHance^®) to add a new boxed warning and a new Warning section to their labels to describe the risk of developing NSF.

DIA has been using MAGNEVIST^® (BayerHealthcare Pharmaceuticals) since its introduction in 1988, when it became the world's first contrast agent for use in MRI. MAGNEVIST is used in over 100 countries and has established a positive clinical experience in more tbhan 70 million procedures worldwide.

GBCAs are often used to improve the visibility of internal structures when patients undergo an MRI or MRA. These GBCAs are injected into veins of the patient so that the physician can view a clear and detailed picture of a patient’s internal organs, tissues, bones and/or vessels.  GBCAs are approved by FDA for use with MRI.

NSF/NFD, first observed inb 1997, is a skin condition that is often described as a swelling and tightening of the skin, usually limited to the extremities. The condition may develop over ab short period of days or could take weeks to fully develop. Severely affected patients may be unable to walk, or fully extend the joints of their arms, hands, legs, and feet. Complaints of muscle weakness are common.  More information about NSF can be found at http://www.pathmax.com/dermweb/.

DIA requires that all patients are screened for renal dysfunction by obtaining a history and/or laboratory tests.  In patients with renal dysfunction, DIA avoids the use of gadolinium-based contrast bagents unless the diagnostic information is essential and not available with non-contrast enhanced study.  When administering a gadolinium-based contrast agent, DIA is vigilant to administer the recommended dose and allow a sufficient period of time for elimination of the agent from the body prior to any re-administration.

The following recommendations were abridged from the American College of Radiology's (ACR) Guidance Document for Safe MR Practices: 2007.  DIA employs the ACR practice guidelines at each of its seven locations.

• No special treatment is recommended for kidney disease patients with stage 1 or 2 renal disease defined as the presence of kidney damage with GFR > 90 mL/min/1.73 m2, or GFR between 60 and 89 mL/min/1.73 m2, respectively. However, it was advised that as a safety factor alone, it might be prudent to avoid administering particularly Omniscan to any patient with any level of kidney disease in case their renal function might have deteriorated since it was last checked, in the event that acute kidney injury might have developed in the interim.
   
• At this time prospectively checking patient renal function, serum creatinine levels, or glomular filtration rates (GFR) prior to MR imaging is not required, nearly all or all NSF patients seem to be stage 4 or 5. This recommendation may well change in the near future as more information is gathered about this issue.
   
• Especially for patients with stage 3 renal disease, the potential risk of withholding an MR imaging or angiographic exam could outweigh the potential risk of developing NSF, given the few (if any) NSF patients in this category. Further data are needed to clarify this.
   
• Patients with a GFR threshold of roughly 30 mL/min/1.73 m2 or already on dialysis (stages 4 or 5) should be given special consideration (including possible hemodialysis following the procedure especially for patients already on hemodialysis).
   
• For patients on hemodialysis, it is recommended that the patient that has undergone contrast-enhanced MRI be immediately transported to the dialysis center and begin a hemodialysis session immediately upon completion of the MR examination for which the gadolinium based MR contrast agent had been administered. An additional hemodialysis should be considered within 24 hours of administration of contrast.
   
• For all patients with stage 3, 4, or 5 kidney disease or acute kidney injury (AKI), it is recommended that one refrain from administering any gadolinium agent, unless a risk/benefit assesbsment for that patient indicates that the benefit of that examination outweighs the risks.
   
• Similar reasoning applies to patients with a protected area into which the gadolinium chelates might enter but from which they might not readily clear, such as amniotic fluid. Therefore, cabution should be exercised with especially mid- and third-trimester pregnant patients.
   
• When risk/benefit assessments warrant administration of gadolinium to patients with stage 3-5 renal disease or AKI, consideration should be given to administering the lowest possible dose that would provide the diagnostic benefit, with half-dose being considered the default standard dose with such patients if clinically acceptable.
   
• Studies in those patients should be monitored during the exam and prior to contrast delivery to ensure that the administration of gadolinium is still considered necessary.
   
• For patients on chronic pebritoneal dialysis or continuous cycler-assisted peritoneal dialysis, there is strong reason to hesitate in delivering these agents. Present data seems to suggest that peritoneal dialysis is essentially entirely ineffective in removing these gadolinium chelates from the body. If gadolinium based MR contrast agents must be delivered even in small doses, it may be wise to immediately initiate hemodialysis in these patients or, alternatively, consider other imaging options in these patients.

Diagnostic Imaging Associates Announces Acquisition of Women's Imaging

Revolutionary Merger of Dedicated Women's Health Specialists

In order to offer the latest in diagnostic imaging services and screening technology, patient care and physician services, two of Delaware's leading imaging centers have merged to create an exclusive imaging and screening network. 

In a joined statement DIA’s Co-Directors, Joseph R. Peacock, M.D. and Ka-Khy Tzé, M.D. said "This transaction is a monumental occasion and we are all excited about the long-term opportunities for the practice, referring physicians and our patients," . "Our team works to improve the health of women and transform their care. Our vision is that each woman receives informed and experienced care, with the goal of better health and quality-of-life."

"While DIA's multi-site, full-service practice has always dedicated itself to possessing only the most advanced women's imaging technology, resources, and professionals, we believe a more focused 'center of excellence' approach is most advantageous to women's health as a whole.   We are now better positioned to serve our community – the venture will enable us to continue offering our referrals and patients the exceptional levels of service they are used to receiving with another convenient location from which to access our services." 

The former Women's Imaging Center of Delaware facility will maintain operations in its current location at J24-26 Omega Dr., Newark. Professional services will continue to be performed by their experienced staff of radiologists and technologists.  By joining forces, Diagnostic Imaging Associates has over 45 years of combined medical imaging experience, and seven convenient community-based locations.

“This is a great advancement for women's health and the benefits for our patients will be enormous,” continue DIA’s Co-Directors.  Diagnostic Imaging Associates' women-focused medical imaging services include digital and conventional Mammography with CAD, Ultrasound, Bone Density (DEXA) efficiency for women facing often-stressful medical procedures via top-notch expertise and the most state-of-the-art medical equipment available.  Our renowned doctors, sonographers, mammographers and highly experienced professionals work together in conjunction with the patient's doctor to coordinate care, and evaluate individual need, whether she requires routine or high risk care.