Wednesday, 11:50 PM
High-Level Journal Summary: The complex reasons from the FDA behind a simple letter from NIH regarding MRI's. There is a new process in place at NIH which requires patients to get blood work done prior to an MRI to essentially check their kidney function.
The reason for this? There is a new link between contrast agents used during an MRI and something called Nephrogenic Systemic Fibrosis or Nephrogenic Fibrosing Dermopathy (NSF/NFD). My contrast agent for Perfusion MRI's at NIH is called Magnevist, which is a contrast agent that is part of this FDA "Public Health Advisory."
So, the kidney function now needs to be checked before an MRI. However, I have a hard time imagining a scenario as a brain cancer patient where this would stop me from getting an MRI, simply because my brain cancer is my biggest health risk right now, not the function of my kidneys. Still, this is great information for me to have.
Countdowns:
1.) Day 24 of 28 in my 23rd 5/23 Temodar chemotherapy cycle.
2007 Seizure Activity:
1.) Last Simple Partial Seizure, or SPS, was 11 days ago.
2.) In 2007, I have had 31 SPS's in 213 days. This is an average of 1 SPS every 6.9 days.
Website Updates:
1.) An online journal was added today for 1/1/05. In this journal, I was still in the process of figuring out all that needed to be done in my 26th day since diagnosis. I understood that I was in a highly disruptive environment with so many things hitting all at once, and I was just trying to manage everything at the same time. This is a transcription of my handwritten journal from that day.
2.) The July 2007 Awareness Statistics have now been posted:
159,227 people visited 38 Lemon in the last 12 months
23,723 people visited 38 Lemon in July 2007
There were 4,488,096 hits to 38 Lemon in the last 12 months
Actual Journal: I got a somewhat simple letter in the mail from NIH today that changes the overall process for getting my MRI's every two months. When I did some digging with "anonymous inside sources" at NIH, I got the full scoop on what is happening. First the verbatim letter, then the inside scoop.
New policy
Dear Patient,
This letter is to inform you that the National Institutes of Health has instituted a new policy with regards to Radiology appointments here at the NIH.
Radiology appointment include:
MRI Brain
MRI Spine
CT with Contrast
The policy states that every patient scheduled for any of the above tests must complete "pre-radiology" lab work. These labs must be completed at least one hour prior to the radiology appointment.
(I.e. MRI brain scheduled at 2 PM, the labs must be completed before 1pm.)
The lab is open between 7:00am -4:00pm. Outpatient Phlebotomy is not responsible for drawing lab work on any patient that arrives after 4pm, so please plan ahead and arrive early.
Patients that are scheduled for a radiology exam at 7am must complete the lab work the day prior before 4pm.
Patients that are scheduled for a radiology exam after 5pm must come early to accomplish the lab work before 4pm.
NO MRI appointment will be completed if lab work is not done.
Patients that are unable to have labs drawn at the NIH must bring outside lab results in hand to the Radiology department. These outside results must be current (within one week) to the radiology appointment.
If a prescription is needed to complete these labs at an outside facility, please contact the Patient Care Coordinators at 301-402-6298.
Thank you,
Neuro-Oncology Branch Staff
The reason for this
Here is a Public Health Advisory from the FDA which raises concern about using specific contrast agents during Perfusions MRI's, mainly because of a possible disease known as Nephrogenic Systemic Fibrosis or Nephrogenic Fibrosing Dermopathy (NSF/NFD).
As can be seen in my 6/13/06, 12/18/06, and 3/26/07 online journal entries, a contrast agent called Magnevist is used at NIH. This also happens to be a contrast agent that is included in this Public Health Advisory from the FDA, as can be seen in the following notice.
Gadolinium-containing Contrast Agents for Magnetic Resonance Imaging (MRI):
Omniscan, OptiMARK, Magnevist, ProHance, and MultiHance
The FDA is evaluating important safety information about gadolinium-containing contrast agents and a disease known as Nephrogenic Systemic Fibrosis or Nephrogenic Fibrosing Dermopathy (NSF/NFD) that occurs in patients with kidney failure. New reports have identified a possible link between NSF/NFD and exposure to gadolinium containing contrast agents used at high doses for a procedure called Magnetic Resonance Angiography (MRA). An MRA test uses magnetic resonance imaging to take pictures of blood vessels. During an MRA test, a drug known as a gadolinium-contrast agent is injected into a patient’s vein so blood vessels can be distinguished from other nearby tissues.
The FDA has learned of 25 cases of NSF/NFD in patients with kidney failure who received Omniscan®, a gadolinium-containing contrast agent, and took the MRA test. The FDA is actively investigating whether exposure to a gadolinium-contrast agent for MRA is associated with the development of NSF/NFD. While FDA conducts its investigation, the following recommendations are being provided to health care providers and patients:
• Gadolinium-containing contrast agents, especially at high doses, should be used only if clearly necessary in patients with advanced kidney failure (those currently requiring dialysis or with a Glomerular Filtration Rate (GFR) = 15 cc/min or less).
• It may be prudent to institute prompt dialysis in patients with advanced kidney dysfunction who receive a gadolinium contrast MRA. Although there are no data to determine the utility of dialysis to prevent or treat NSF/NSD in patients with decreased kidney function, average excretory rates of gadolinium are 78%, 96%, and 99% in the first to third hemodialysis sessions, respectively (Okada, et al, Acta Radiologica, vol 42 p. 339, May 2001).
Five gadolinium-containing contrast agents are FDA-approved for use during magnetic resonance imaging (MRI), a test that can look at internal body organs and tissues. The trade names of the U.S. approved gadolinium-containing contrast agents are: Omniscan, OptiMARK, Magnevist, ProHance, and MultiHance. None of these drugs are FDA approved for MRA. The dose of gadolinium-containing contrast agent given to patients undergoing an MRA test is often higher (up to three times) than the approved dose for MRI.
NSF/NFD appears to occur in patients with kidney failure along with high levels of acid in body fluids a condition known as acidosis that is common in patients with kidney failure. Patients with NSF/NFD have tight and rigid skin making it difficult to bend joints. NSF/NFD may also result in fibrosis, or scarring, of body organs resulting in the inability of body organs to work properly and can lead to death. Diagnosis of NSF/NFD is done by looking at a sample of skin under a microscope.
Scientists first identified NSF/NFD in 1997 and the cause of NSF/NFD is unknown. Worldwide, there are approximately 200 reports of NSF/NFD.
The 25 cases of NSF/NFD were reported on May 29, 2006, by the Danish Medicines Agency. Among these, 20 cases occurred in Denmark and five cases occurred in Austria. The patients developed NSF/SFD within 3 months (range 2 weeks to 3 months) after receiving the gadolinium-containing contrast agent. The five patients from Austria are described in a publication: Grobner T. Gadolinium – a specific trigger for the development of nephrogenic fibrosing dermopathy and nephrogenic systemic fibrosis Nephrol dial Transplant. 21(4):1104-8.
The FDA has not yet determined whether exposure by patients with kidney failure to gadolinium-containing contrast agents during an MRA test causes NSF/NFD. The FDA is gathering additional information about NSF/NFD and investigating whether other patients who received gadolinium-containing contrast agents developed NSF/NFD.
The FDA urges health care providers and patients to report adverse event information to the FDA via the MedWatch program by phone (1-800-FDA-1088), by fax (1-800-FDA-0178), or by the Internet at http://www.fda.gov/medwatch/index.html.
What does all this translate to?
I talked with a CRNP at NIH on 7/31/07 about this issue, specifically. I tried to have all this translated to English, if you will. My understanding is that there is concern about the potential impact to a patient's kidney. There is a link between these contrast agents and how fibrous a kidney becomes.
Specifically, there is a link between certain contrast agents used in MRI's and a disease known as Nephrogenic Systemic Fibrosis or Nephrogenic Fibrosing Dermopathy (NSF/NFD). So, blood tests are now done beforehand to essentially test how a patient's kidney is doing. It is the recommendation of numerous medical studies that this be done prior to MRI's.
The only other thing I saw that was helpful to me (as a patient) was from the American Journal of Roentgenology. A publication within this website gave the following Nephrogenic Systemic Fibrosis (NSF) symptoms. These are "watch items" for patients, if you will.
The signs and symptoms of NSF include:
• For the skin—burning or itching, reddened or darkened patches; and/or skin swelling, hardening and/or tightening
• For the eyes—yellow raised spots on the whites of the eyes
• For the bones, joints and muscles—joint stiffness; limited range of motion in the arms, hands, legs, or feet; pain deep in the hip bone or ribs; and/or muscle weakness.
Bottom line
To my non-medical set of eyes, I have a hard time imagining NOT getting an MRI. This new testing sounds like the FDA and NIH are both erring on the side of caution. However, when dealing with brain cancer, my brain cancer once again outweighs other health risks -- which now also includes Nephrogenic Systemic Fibrosis (NSF).
All that said, I will start asking questions about why the skin around my eyes turns red periodically. Is there any link between this and NSF? The upcoming phlebotomy tests on my kidney should answer that question very quickly.
