ACR Manal on MRI safety
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Questions and Answers

What is NSF?

  • A rare complication after GBCA administration in patients with CKD (correct)
  • A rare complication after GBCA administration in patients with AKI
  • A rare complication after GBCA administration in children
  • A rare complication after GBCA administration in all patients

    • What is NSF?

  • A rare but potentially life-threatening complication (correct)
  • A rare but non-life-threatening complication
  • A common but potentially life-threatening complication
  • A common but non-life-threatening complication

    • What is the range of adverse event rate for GBCM administered at clinical doses?

  • 0.07% to 0.2%
  • 0.07% to 0.7%
  • 0.07% to 2.4% (correct)
  • 0.004% to 0.2%

    • What is the correct classification of an allergic-like contrast reaction?

    <p>Idiosyncratic</p> Signup and view all the answers

    Which of the following should be done before administering a Group I or Group III GBCA?

    <p>Identifying and screening for conditions that may impair renal function</p> Signup and view all the answers

    What is the recommended time period for abstaining from breast-feeding after contrast administration?

    <p>24 hours</p> Signup and view all the answers

    What is the most common type of adverse event associated with LOCM?

    <p>Allergic-like reactions</p> Signup and view all the answers

    What is the FDA's recommendation regarding the use of Group I agents in patients at risk of NSF?

    <p>They should be contraindicated</p> Signup and view all the answers

    What is the treatment for an allergic-like contrast reaction?

    <p>Treat the symptoms</p> Signup and view all the answers

    What is the most common GBCA responsible for NSF?

    <p>Gadodiamide</p> Signup and view all the answers

    What is the amount of contrast medium that is excreted into the breast milk and absorbed by the infant?

    <p>Low</p> Signup and view all the answers

    What is the most likely agent to cause NSF?

    <p>Group I agents</p> Signup and view all the answers

    What is the usual manifestation of an allergic-like reaction to a GBCM?

    <p>All of the above</p> Signup and view all the answers

    What is the reported incidence of delayed allergic-like reactions?

    <p>0.5% - 14%</p> Signup and view all the answers

    When should an eGFR level be obtained before administering a Group I or Group III GBCA?

    <p>Within 2 days</p> Signup and view all the answers

    What is the frequency of severe lifethreatening anaphylactic reactions to GBCM?

    <p>0.001% to 0.01%</p> Signup and view all the answers

    What is the most substantial risk factor for a recurrent allergic-like adverse event?

    <p>Prior allergic-like reaction to ICM</p> Signup and view all the answers

    Who is at increased risk of developing NSF?

    <p>Patients with AKI</p> Signup and view all the answers

    Who is at an increased risk for developing nephrogenic syndrome due to exposure to gadolinium-containing contrast agents?

    <p>Patients with severe kidney disease</p> Signup and view all the answers

    What is the most common type of reaction to ICM?

    <p>Vasovagal reaction</p> Signup and view all the answers

    What is the benefit to continuing breast-feeding beyond 24 hours after contrast administration?

    <p>None</p> Signup and view all the answers

    What type of reaction is more common in patients with systemic lupus erythematosus?

    <p>Severe cutaneous reactions</p> Signup and view all the answers

    What is the likely cause of vasovagal reactions?

    <p>Anxiety</p> Signup and view all the answers

    What is the frequency of allergic-like reactions to gadolinium chelate agents?

    <p>0.004% to 0.7%</p> Signup and view all the answers

    Can GBCA be safely administered to all patients with CKD?

    <p>Yes</p> Signup and view all the answers

    For which of the following patients would it be reasonable to consider administering iodinated contrast media and performing a CT rather than an MRI?

    <p>An anuric patient with no residual renal function</p> Signup and view all the answers

    What is believed to be the mechanism by which gadolinium causes nephrogenic syndrome?

    <p>The gadolinium dissociates from the chelates in the contrast agent</p> Signup and view all the answers

    How is breast-feeding generally safe for the mother and infant when a gadolinium-based contrast medium is administered?

    <p>The amount of contrast medium is low and unlikely to cause harm.</p> Signup and view all the answers

    Is the detection of gadolinium in tissues required to make the diagnosis of nephrogenic syndrome?

    <p>No</p> Signup and view all the answers

    What is the cause of nephrogenic systemic fibrosis?

    <p>GBCM administered to patients with acute kidney injury or severe chronic kidney disease</p> Signup and view all the answers

    Which of the following is NOT recommended after contrast administration?

    <p>Increasing the amount of breast milk</p> Signup and view all the answers

    What is the most likely explanation for the rarity of serious physiologic reactions to ICM?

    <p>Unknown threshold</p> Signup and view all the answers

    What should be used to administer GBCAs in premature infants and neonates?

    <p>Group II agents</p> Signup and view all the answers

    What is the most common time of year for delayed cutaneous adverse events to occur?

    <p>Summer</p> Signup and view all the answers

    What is the recommended dose of GBCA for at-risk patients?

    <p>The recommended single dose</p> Signup and view all the answers

    What may help explain why the various GBCAs differ in their apparent NSF safety profile in at-risk patients?

    <p>The propensity for gadolinium to dissociate from various chelates</p> Signup and view all the answers

    What is the risk factor for having an allergic-like reaction to GBCM?

    <p>Having a previous reaction to GBCM</p> Signup and view all the answers

    What is the primary difference between an allergic reaction and an allergic-like contrast reaction?

    <p>Antigen-antibody response</p> Signup and view all the answers

    What type of reaction has been reported to range from 0.5% to 14%?

    <p>Delayed allergic-like reactions</p> Signup and view all the answers

    What is the ACR Committee on Drugs and Contrast Media's recommendation regarding the optimal time interval between eGFR determination and GBCA injection?

    <p>There is no scientific evidence to guide the time interval</p> Signup and view all the answers

    When should an eGFR test be recommended?

    <p>If you have one or more risk factors for renal disease</p> Signup and view all the answers

    What is the purpose of expressing and discarding breast milk after contrast administration?

    <p>To reduce the amount of contrast medium in the milk</p> Signup and view all the answers

    How likely is it for patients with end-stage kidney disease and on dialysis to develop NSF?

    <p>Likely</p> Signup and view all the answers

    What is the committee's recommendation regarding the use of Group II agents in patients at risk of NSF?

    <p>They should be used with caution</p> Signup and view all the answers

    Which of the following is true about LOCM?

    <p>They are associated with a very low incidence of acute adverse events.</p> Signup and view all the answers

    How often should an eGFR test be done if your eGFR is 44 or below?

    <p>Every two days</p> Signup and view all the answers

    What is the primary difference between LOCM and vasovagal reactions?

    <p>Adverse event profile</p> Signup and view all the answers

    What is the treatment for acute adverse reactions to GBCM?

    <p>Treatment similar to iodinated contrast media</p> Signup and view all the answers

    What should the mother do if she is concerned about any potential ill effects to the infant?

    <p>Abstain from breast-feeding for 12 to 24 hours</p> Signup and view all the answers

    What is the effect of GBCM on pain in patients with chronic pain conditions?

    <p>Reduce pain</p> Signup and view all the answers

    What is the main risk associated with administering a gadolinium-based contrast medium?

    <p>Harmful effects to the infant</p> Signup and view all the answers

    What is the committee's recommendation regarding the use of Group I agents in patients at risk of NSF?

    <p>They should be contraindicated</p> Signup and view all the answers

    Who is more likely to develop NSF?

    <p>Patients with severe kidney disease</p> Signup and view all the answers

    How often should an eGFR test be done if your eGFR is 60 or above?

    <p>Once a year</p> Signup and view all the answers

    What type of reaction is more common in patients treated with interleukin-2 (IL-2) therapy?

    <p>Delayed allergic-like reactions</p> Signup and view all the answers

    What is the likely cause of cardiogenic pulmonary edema?

    <p>Underlying cardiac disease</p> Signup and view all the answers

    What is the FDA's stance on off-label use of GBCM?

    <p>Not approved</p> Signup and view all the answers

    What is the main benefit of administering a gadolinium-based contrast medium?

    <p>Improved imaging of the body</p> Signup and view all the answers

    What type of reaction may occur up to one week after the injection of ICM?

    <p>Allergic-like reactions</p> Signup and view all the answers

    What is the primary symptom of vasovagal reactions?

    <p>Apprehension</p> Signup and view all the answers

    What is the most common GBCA responsible for NSF?

    <p>Gadodiamide</p> Signup and view all the answers

    What is the most likely cause of eGFR values in premature infants and neonates?

    <p>Immature renal function</p> Signup and view all the answers

    What is the recommendation for patients with AKI and CKD?

    <p>The initiation or alteration of dialysis should not be based on the results of a contrast-enhanced MR examination</p> Signup and view all the answers

    What should be used to administer GBCAs in patients with CKD?

    <p>Group II agents</p> Signup and view all the answers

    What is the recommended course of action for the mother if she is concerned about any potential ill effects to the infant?

    <p>Abstain from breast-feeding for 12 to 24 hours</p> Signup and view all the answers

    What is the primary factor in determining the frequency and significance of cardiovascular effects?

    <p>Underlying cardiac disease</p> Signup and view all the answers

    What should be done if an exception to the recommendations is made?

    <p>Documentation of the rationale for the exception is recommended</p> Signup and view all the answers

    Is NSF more likely to occur in patients who have received high doses of GBCAs?

    <p>Yes</p> Signup and view all the answers

    What is the main concern with extremely high doses of GBCM?

    <p>Nephrogenic systemic fibrosis</p> Signup and view all the answers

    What type of reaction is more common than is generally recognized?

    <p>Delayed cutaneous adverse events</p> Signup and view all the answers

    Study Notes

    • The adverse event rate for GBCM administered at clinical doses (0.1–0.2 mmol/kg for most GBCM) ranges from 0.07% to 2.4%.
    • Most reactions are mild and physiologic, including coldness, warmth, or pain at the injection site; nausea with or without vomiting; headache; paresthesias; and dizziness.
    • Allergic- like reactions are uncommon and vary in frequency from 0.004% to –0.7%.
    • The manifestations of an allergic- like reaction to a GBCM are similar to those of an allergic-like reaction to an iodinated contrast medium.
    • Severe lifethreatening anaphylactic reactions occur [1-6] but are exceedingly rare (0.001% to 0.01%) [7-9] In an accumulated series of 687,000 doses there were only five severe reactions.
    • In a survey of 20 million administered doses, there were 55 severe reactions.
    • A large single-institution study that included more than 100,000 GBCM injections demonstrated an allergic-like reaction frequency of 0.15%, with 0.13% mild reactions and 0.006% severe reactions (six reactions).
    • Fatal reactions to gadolinium chelate agents occur but are extremely rare [12].
    • GBCM administered to patients with acute kidney injury or severe chronic kidney disease can result in a syndrome of nephrogenic systemic fibrosis (NSF).
    • For more information, see the chapter on Nephrogenic Systemic Fibrosis.
    • GBCM are not considered nephrotoxic at dosages approved for MR imaging.
    • Risk Factors
    • The frequency of acute adverse reactions to GBCM is about eight times higher in patients with a previous reaction to GBCM.
    • At many institutions, a prior allergic-like reaction to GBCM is often an indication for corticosteroid prophylaxis prior to subsequent exposures.
    • One GBCM, gadobenate dimeglumine, has FDA labeling contraindicating use in patients who have a history of an allergic-like reaction to GBCM.
    • Some reports have suggested that GBCM that have been most commonly associated with NSF are less likely to be associated with allergic-like reactions and vice versa [15].
    • Patients with asthma and various other allergies may have a mild increased risk for an allergic-like reaction to GBCM compared to the general population, but many institutions do not have special procedures for these patients given the extremely low overall reaction rate for GBCM.
    • There is no cross-reactivity
    • There is low risk to patients with sickle cell disease from IV-administered GBCM at approved dosages.
    • Breath-holding difficulty with gadoxetate disodium is a transient phenomenon that is unique to this agent and is self-limited.
    • Treatment of acute adverse reactions to GBCM is similar to that for acute reactions to iodinated contrast media.
    • Extravasation events to GBCM are rare. Laboratory studies in animals have demonstrated that both gadopentetate dimeglumine and gadoteridol are less toxic to the skin and subcutaneous tissues than are equal volumes of iodinated contrast media.
    • Serum calcium determinations may be impaired by some linear nonionic GBCM (e.g., gadoversetamide, gadodiamide). However, these GBCM do not cause acute calcium toxicity.
    • GBCM has been shown to be effective in the treatment of various conditions, including reducing pain in patients with chronic pain conditions and reducing inflammation.
    • However, GBCM can also have side effects, including reduced levels of serum calcium.
    • Off-label use of GBCM is not approved by the FDA, but can be justified in individual cases as long as the physician can provide evidence of clinical necessity.
    • Extremely high doses of GBCM have largely been abandoned due to concerns about nephrogenic systemic fibrosis.

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    Description

    Test your knowledge about the adverse reactions and risk factors associated with the use of gadolinium-based contrast agents (GBCM) in medical imaging. Learn about the frequency, manifestations, and treatment of allergic-like reactions, rare severe reactions, and the syndrome of nephrogenic systemic fibrosis (NSF) associated with GBCM.

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