The Reveal Image Challenge | Guerbet Presents First Image of the Year Award
WARNING: RISK ASSOCIATED WITH INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS (NSF)
Risk Associated with Intrathecal Use
Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures.
ELUCIREM is not approved for intrathecal use.
Nephrogenic Systemic Fibrosis
GBCAs increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of ELUCIREM in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs.
The risk for NSF appears highest among patients with:
- Chronic, severe kidney disease (GFR <30 mL/min/1.73 m2), or
- Acute kidney injury.
Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (for example, age >60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.
For patients at highest risk for NSF, do not exceed the recommended ELUCIREM dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration.
See Elucirem™ (gadopiclenol) injection full prescribing information and additional Important Safety Information located at the bottom of this article.
In early 2023, Guerbet partnered with Applied Radiology to launch The Reveal Image Challenge, a program that provides US-based MR imaging professionals an opportunity to reveal their MR imaging potential by sharing MR images using Elucirem™ (gadopiclenol) injection.
Image of the Month winners were selected from among a pool of images submitted by medical imaging professionals throughout the US. Each monthly winner was then voted upon for Image of the Year recognition and announced at the 2023 Radiological Society of North America (RSNA) Scientific Assembly and Annual Meeting.
During a special event at RSNA, Guerbet presented the first Image of the Year award to John W. Gianini, MD, a radiologist at Radiology Associates in Daytona Beach, Florida, for his contrast-enhanced MR image demonstrating neurological pathology.
“We're thrilled to be part of The Reveal Image Challenge,” said Dr Gianini. “We like being on the cutting edge and trying new things, so we were very interested in using Elucirem. We liked that it offered increased relaxivity and stability at a lower gadolinium dose compared to other MRI contrast agents.”
To be considered for the Image of the Year award, all submitted Elucirem images had to abide by the established submission criteria stating they must be the approved FDA indications and approved dose administration. The members of the 2023 review committee were Bill Faulkner, BSRT(R)(MR)(CT),MRSO (MRSC™), William Faulkner & Associates; Blake Johnson, MD, medical director at RAYUS Radiology; Donna Roberts, MD, MS, a professor in the Department of Radiology and Radiological Sciences at the Medical University of South Carolina; and Jeffrey Weinreb, MD, chief of radiology services and director of MRI Services at Yale New Haven Hospital.
“The image that Dr. Gianini submitted was outstanding and clearly demonstrated the clinical benefits of Elucirem. The review committee agreed that it should be selected as Image of the Year. We're very appreciative of Dr. Gianini’s interest in Elucirem and for his participation in The Reveal Image Challenge,” said Jamie Kulow, senior product manager for Contrast Media at Guerbet.
Jared Houk, commercial vice president of Guerbet of North America, said The 2023 Reveal Image Challenge reached more than 2 million members of the imaging community through digital marketing efforts. Houk said he believes the program was successful because it solicited “unfiltered” images from the MRI community, including radiologists, technologists, and directors of radiology.
“The best thing about The Reveal Image Challenge is presenting the award at RSNA. It was a lot of fun bringing everyone together with the opportunity to talk about the innovation in MR contrast technology and Elucirem. That's what RSNA is all about, learning from our customers, learning from their interactions with patients and how we can improve patient care,” said Houk.
Reveal Your MR Imaging Potential in 2024
Houk encourages the entire radiology community to participate in The Reveal Image Challenge throughout 2024. “This program is all about the fun of developing and sharing Elucirem experience and images with colleagues. At Guerbet, we want to show what Elucirem can deliver for the imaging community for its patients,” he said.
Contrast-enhanced MR images using Elucirem and supporting case information can be submitted online through October 2024. Submitted images will be considered for Image of the Month recognition and Image of the Year, to be awarded at RSNA 2024.
“This is a wonderful way to showcase what radiologists are doing on a daily basis while administering half the conventional dose of gadolinium. We're excited to partner with the radiology community so they can share their work,” said Kulow.
About Elucirem
Elucirem™ (gadopiclenol) injection, invented by Guerbet and approved for use in the US in September 2022, is a highly stable macrocyclic gadolinium-based contrast agent (GBCA). It has the highest relaxivity in its class for MR imaging and is indicated for use in adults and children aged 2 years and older for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in the central nervous system (brain, spine, and associated tissues), and the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).1
It is important to note that Guerbet received FDA marketing approval of Elucirem after priority review, a designation assigned to drugs that provide significant improvements over other therapies in safety, prevention, diagnosis, and the treatment of serious conditions.5
References
- Elucirem [package insert]. Princeton, NJ: Guerbet LLC; 2024
- Robic C, Port M, Rousseaux O, et al. Physicochemical and pharmacokinetic profiles of gadopiclenol: a new macrocyclic gadolinium chelate with high T1 relaxivity. Invest Radiol. radiology. 2019; 54(8), 475–484. https://doi.org/10.1097/RLI.0000000000000563
- Loevner LA, Kolumban B, Hutóczki G, et al. Efficacy and safety of gadopiclenol for contrast-enhanced MRI of the central nervous system: The PICTURE Randomized Clinical Trial. Invest Radiol. 2023 May 1;58(5):307-313 . 10.1097/RLI.0000000000000944. doi: 10.1097/RLI.0000000000000944. Epub 2022 Dec 19.
- Data on file (PROMISE trial. GDX-44-011).
- US FDA. Priority Review. Available at: https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-review. Accessed January 29, 2024.
ELUCIREMTM (gadopiclenol) injection Important Safety Information
Indications and Usage
ELUCIREMTM (gadopiclenol) injection is indicated in adult and pediatric patients aged 2 years and older for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in the central nervous system (brain, spine, and associated tissues), and the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).
Contraindications
Contraindicated in patients with history of hypersensitivity reactions to ELUCIREM.
Warnings and Precautions
- Risk Associated with Intrathecal Use: Intrathecal administration of GBCAs can cause serious adverse reactions including death, coma, encephalopathy, and seizures. The safety and effectiveness of ELUCIREM have not been established with intrathecal use. ELUCIREM is not approved for intrathecal use.
- Nephrogenic Systemic Fibrosis: GBCAs increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of ELUCIREM among these patients unless the diagnostic information is essential and not available with non-contrast MRI or other modalities.
- Hypersensitivity Reactions: With GBCAs, serious hypersensitivity reactions have occurred. Before ELUCIREM administration, assess all patients for any history of a reaction to contrast media, bronchial asthma and/or allergic disorders. These patients may have an increased risk for a hypersensitivity reaction to ELUCIREM.
- Gadolinium Retention: Gadolinium is retained for months or years in several organs. The highest concentrations have been identified in the bone, followed by other organs (e.g. brain, skin, kidney, liver, and spleen). While clinical consequences of gadolinium retention have not been established in patients with normal renal function, certain patients might be at higher risk. These include patients requiring multiple lifetime doses, pregnant and pediatric patients, and patients with inflammatory conditions. Minimize repetitive GBCA imaging studies, particularly closely spaced studies when possible.
- Acute Kidney Injury: In patients with chronically reduced renal function, acute kidney injury requiring dialysis has occurred with the use of GBCAs. The risk of acute kidney injury may increase with increasing dose of the contrast agent.
- Extravasation and Injection Site Reactions: Injection site reactions such as injection site pain have been reported in the clinical studies with ELUCIREM. Extravasation during ELUCIREM administration may result in tissue irritation. Ensure catheter and venous patency before the injection of ELUCIREM.
- Interference with Visualization of Lesions Visible with Non-Contrast MRI: As with any GBCA, ELUCIREM may impair the visualization of lesions seen on non-contrast MRI.
Adverse Reactions:
In clinical trials, the most frequent adverse reactions that occurred in > 0.2% of patients who received ELUCIREM included: injection site pain, headache, nausea, injection site warmth, injection site coldness, dizziness, and localized swelling.
Use in Specific Populations
- Pregnancy: GBCAs cross the human placenta and result in fetal exposure and gadolinium retention. There are no available data on ELUCIREM use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.
- Lactation: There are no data on the presence of ELUCIREM in human milk, the effects on the breastfed infant, or the effects on milk production. However, published lactation data on other GBCAs indicate that 0.01 to 0.04% of the maternal gadolinium dose is excreted in breast milk.
- Pediatric Use: The safety and effectiveness of ELUCIREM have not been established in pediatric patients younger than 2 years of age.
- Geriatric Use: This drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function.
- Renal Impairment: In patients with renal impairment, the exposure of gadopiclenol is increased compared to patients with normal renal function. This may increase the risk of adverse reactions such as NSF. No dose adjustment of ELUCIREM is recommended for patients with renal impairment.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see the full Prescribing Information, including the Medication Guide, for additional important safety information.
This website is intended for US healthcare professionals only.
For more information about Elucirem™ (gadopiclenol) injection visit: https://www.guerbet.com/en-us/products-solutions/contrast-agents/elucirem-gadopiclenol-injection
The Elucirem Reveal Image Challenge program will continue in 2024, leading the Image of the Year announcement. To submit Elucirem images for consideration, visit https://appliedradiology.com/reveal
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