Dotarem (gadoterate meglumine) / Guerbet - LARVOL DELTA

Dosimetric Evaluation of the Sensitivity of PAGAT Gel Dosimeters Infused with Clinically Used Gadolinium-Based Contrast Agents. (PubMed, Gels) - "This study evaluates the impact of gadolinium-based contrast agents (Omniscan, Dotarem, and Gadovist) on the performance of PAGAT gel dosimeters using spectrophotometric analysis...Additionally, gadolinium-infused PAGAT gels show strong potential for assessing dose enhancement phenomena. Their sensitivity, threshold behavior, and radiological properties suggest they may be suitable for applications in dose enhancement dosimetry as well as conventional clinical settings."

Journal

Gadopiclenol Versus Gadoterate Meglumine for Pediatric Brain MRI: An Intraindividual Comparison of Contrast Enhancement. (PubMed, AJR Am J Roentgenol) - " The findings support use of gadopiclenol at half the standard gadolinium dose for pediatric brain MRI examinations. Clinical Impact: Use of gadopiclenol could facilitate reductions in cumulative gadolinium exposure in children requiring serial MRI examinations."

Journal • Pediatrics

Renal perfusion assessment by magnetic resonance imaging in patients with diabetic cardiac autonomic neuropathy (ERA 2025) - "The contrast agent Dotarem (Gd-DOTA) was injected intravenously to enhance the visualisation of the kidneys, providing high-resolution images and quantifiable data on renal blood flow... This study investigated the impact of CAN on renal perfusion in individuals with type 1 and type 2 diabetes using DCE-MRI. The findings showed no significant differences in renal perfusion between 'no CAN' and 'CAN' group, challenging previous assumptions of its impact on renal perfusion due to sympathetic over activity. These outcomes highlight the need for future longitudinal studies with larger sample sizes."

Clinical • MRI • Acute Kidney Injury • Chronic Kidney Disease • Diabetic Nephropathy • Diabetic Neuropathy • Hepatology • Nephrology • Oncology • Pain • Renal Disease • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

Overall Gadolinium Exposure Within the First 5 Months After Injection of Human Equivalent Doses of Gadopiclenol, Gadoterate, or Gadobutrol in Healthy Rats. (PubMed, Invest Radiol) - "Under our experimental conditions, the overall measured Gd exposure over 5 months following gadopiclenol injection in rats at the HED is 25-40% lower than that after gadoterate and gadobutrol injections, respectively."

Journal • Preclinical

FUS-AD: Neuronavigation-guided FUS-induced BBB Opening in Alzheimer's Disease Patients and Its Effects on Brain Amyloid and Tau (clinicaltrials.gov) - P1 | N=6 | Not yet recruiting | Sponsor: Columbia University | Trial completion date: Dec 2026 ➔ Dec 2027 | Initiation date: Jun 2025 ➔ Aug 2026 | Trial primary completion date: Jul 2026 ➔ Jul 2027

Trial completion date • Trial initiation date • Trial primary completion date • Alzheimer's Disease • CNS Disorders

Collagen-targeted PET Imaging for Early Interstitial Lung Disease (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Massachusetts General Hospital | Trial completion date: Apr 2025 ➔ Apr 2026 | Trial primary completion date: Apr 2025 ➔ Apr 2026

Trial completion date • Trial primary completion date • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases

Quanti CNS: A Study to Compare How Well Gadoquatrane Works and Its Safety With an Already Available Contrast Agent for MRI in People With Known or Suspected Brain or Spinal Cord-related Problems (clinicaltrials.gov) - P3 | N=303 | Completed | Sponsor: Bayer | Trial completion date: May 2024 ➔ Dec 2024

Trial completion date

Contrast Agent-Specific Parameter Optimization for T1-Weighted Fast Spoiled Gradient Echo Imaging: Use Cases for Gadoterate Meglumine and Gadobutrol at 1.5T and 3.0T. (PubMed, Invest Radiol) - "Adjusted repetition time and flip angle values, derived using the proposed framework, improved the image contrast between healthy and diseased tissues, enhancing the visualization of abnormalities. This approach can be used to optimize routine clinical MRI protocols and balance scan time with contrast enhancement. This may translate to more precise lesion detection, potentially leading to earlier and more accurate diagnosis or treatment monitoring in clinical practice."

Journal

GDX-44-016: Performance of Elucirem® in DSC-MRI Perfusion of Brain Gliomas (clinicaltrials.gov) - P3 | N=138 | Completed | Sponsor: Guerbet | Recruiting ➔ Completed | Trial completion date: Apr 2024 ➔ Nov 2024 | Trial primary completion date: Apr 2024 ➔ Nov 2024

Trial completion • Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Glioma • Oncology • Solid Tumor

FROP-1 peptide-conjugated ultrasmall superparamagnetic nanoparticles as a targeted T1-weighted MR contrast agent for breast cancer: in vitro study. (PubMed, BMC Biomed Eng) - "It was found that the contrast intensity of the Fe3O4@FROP-1 nanoprobe increases as Fe concentration increases. Cellular uptake of the Fe3O4 and Fe3O4@FROP-1 NPs was quantified using ICP-MS. The synthesized NPs had better imaging performance than Dotarem (gadoterate meglumine). The findings showed that Fe3O4@FROP-1 NPs have potential utility as a specific and targeted T1-weighted contrast agent in breast cancer MR imaging."

Journal • Preclinical • Breast Cancer • Oncology • Solid Tumor

Safety of Gadoterate Meglumine: A Review of 35 Years of Clinical Use and More Than 170 Million Doses. (PubMed, Invest Radiol) - "Clinical evidence from the published data and pharmacovigilance monitoring demonstrated that gadoterate meglumine is a safe magnetic resonance imaging contrast agent for all age groups in a variety of approved indications throughout the whole body, including in patients with renal impairment."

Journal • Dermatology • Fibrosis • Immunology • Renal Disease • Urticaria

Case 336: Canavan Disease. (PubMed, Radiology) - "No swallowing difficulties or seizures were reported, and long-term electroencephalographic monitoring revealed no abnormalities. The patient underwent 3-T MRI (Siemens Healthineers) of the brain, including morphologic sequences and spectroscopy, under general anesthesia with and without gadolinium-based contrast media administration (Dotarem; Guerbet)."

Journal • Anesthesia • CNS Disorders • Developmental Disorders • Epilepsy

FUS-AD: Neuronavigation-guided FUS-induced BBB Opening in Alzheimer's Disease Patients and Its Effects on Brain Amyloid and Tau (clinicaltrials.gov) - P1 | N=6 | Not yet recruiting | Sponsor: Columbia University | Trial completion date: Dec 2025 ➔ Dec 2026 | Initiation date: Oct 2024 ➔ Jun 2025 | Trial primary completion date: Jul 2025 ➔ Jul 2026

Trial completion date • Trial initiation date • Trial primary completion date • Alzheimer's Disease • CNS Disorders

Exploring Gadolinium Deposition in Maternal and Offspring Mice: Impacts of Gestational and Lactational Exposure. (PubMed, Toxicol Lett) - "To investigate the gadolinium deposition induced by repeated administration of gadolinium-based contrast agents (GBCAs) in multi-organ/tissue of mother and pup mice during pregnancy and lactation, two hundred and seventy ICR mice were divided into three groups (non-pregnant, pregnant, and lactating; n=90/group) and received gadodiamide, gadoterate meglumine, or saline intravenously (2.5mmol Gd/kg once every two days for a total of 10 doses) throughout the entire gestation or lactation period...Our results showed that (i)exposure to GBCAs during pregnancy resulted in gadolinium deposition in fetal organs more significantly with gadodiamide, with the greatest deposition observed in the kidneys and the least in the brain, interestingly, the fetal body was found with no detectable gadolinium deposits one month after birth, that (ii) exposure to GBCAs during lactation did not result in detectable gadolinium deposition in the organs/tissues of the unweaned pups, and that..."

Journal • Preclinical

Dotarem vs Gadobutrol Contrast for Breast MRI (clinicaltrials.gov) - P4 | N=258 | Recruiting | Sponsor: University of Massachusetts, Worcester | Trial primary completion date: Mar 2025 ➔ Jul 2025

Trial primary completion date

Concentration-dependent bidirectional modification of evoked synaptic transmission by gadolinium and adverse effects of gadolinium-based contrast agent. (PubMed, J Neurosci) - "Gadoterate meglumine (Magnescope, 100 μM), a macrocyclic GBCA, did not affect synaptic transmission. However, gadopentetate dimeglumine (Magnevist, 100 μM), a liner GBCA, enhanced synaptic transmission, suggesting that gadopentetate dimeglumine does not fully chelate gadolinium, which can have a negative effect on brain function."

Adverse events • Journal • CNS Disorders • Depression • Psychiatry

Developing a New Metabolic Imaging Approach (aMRI) for Evaluating Neurological Disease in Patients With Gliomas (clinicaltrials.gov) - P=N/A | N=20 | Recruiting | Sponsor: OHSU Knight Cancer Institute | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Dec 2024 ➔ Dec 2025

Trial completion date • Trial primary completion date • Brain Cancer • CNS Disorders • CNS Tumor • Glioma • Oncology • Solid Tumor

Precipitation of gadolinium from magnetic resonance imaging contrast agents may be the Brass tacks of toxicity. (PubMed, Magn Reson Imaging) - "Herein, we describe the decomposition of the commercial magnetic resonance imaging contrast agents Omniscan and Dotarem in the presence of oxalic acid, a well-known endogenous compound...Displacement reactions could occur at lysosomal pH. Through these studies, we have demonstrated that magnetic resonance imaging contrast agents can be dissociated by endogenous molecules, thus illustrating a metric by which gadolinium-based contrast agents (GBCAs) might be destabilized in vivo."

Journal • Fibrosis • Immunology

Inequity of access to contrast-enhanced cardiovascular magnetic resonance in patients with chronic kidney disease: A survey from the British Society of Cardiovascular Magnetic Resonance. (PubMed, J Cardiovasc Magn Reson) - "One in five centers across the UK do not offer contrast-enhanced CMR to patients with stage 4 and 5 CKD. This finding serves as a call for updated guidance with the intention of standardizing care."

Journal • Cardiovascular • Chronic Kidney Disease • Fibrosis • Immunology • Nephrology • Renal Disease

Electrochemical Filtration of Gadolinium from Patient Urine after Magnetic Resonance Imaging. (PubMed, ACS Appl Mater Interfaces) - "For macrocyclic Gd-based contrast agents such as gadoterate meglumine (GdDOTA), the Gd trapping efficiency decreased to 25.4% due to the slow dissociation kinetics of macrocyclic contrast agents...After thermal treatment, the reclaimed Gd from the real urine sample was primarily identified as GdPO4. This electrochemical filtration design offers a straightforward and practical approach to recovering Gd from contrast-enhanced MRI scans, addressing the increasing demand for Gd and helping alleviate concerns about Gd contamination in surface water."

Journal

Case 336. (PubMed, Radiology) - "No swallowing difficulties or seizures were reported, and long-term electroencephalographic monitoring revealed no abnormalities. The patient underwent 3-T MRI (Siemens Healthineers) of the brain, including morphologic sequences and spectroscopy (Figs 1-4), under general anesthesia with and without gadolinium-based contrast media administration (Dotarem; Guerbet)."

Journal • Anesthesia • CNS Disorders • Developmental Disorders • Epilepsy

Gadolinium Retention in Human Bone Tissue in Pediatric Patients (clinicaltrials.gov) - P=N/A | N=57 | Completed | Sponsor: Donna Roberts | Recruiting ➔ Completed

Trial completion • Pediatrics

Anaphylactic risk associated with iodinated and gadolinium-based contrast media. (PubMed, Expert Opin Drug Saf) - "Among the macrocyclic agents, gadoteridol had the highest ROR (37.3), while gadoterate meglumine had the lowest (10.4)...The mortality rate in ICM was significantly higher than that in GBCM (p < 0.001). This study provides clinicians and pharmacists evidence for risk signals of anaphylactic reactions among contrast agents."

Journal • Immunology

A First-in-human Study to Investigate Safety and Tolerability of SAR446959 in Participants With Osteoarthritis of the Knee (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: Sanofi

New P1 trial • Immunology • Osteoarthritis • Pain • Rheumatology

Advanced Imaging for Pulmonary Fibrosis (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Peter Caravan | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Pulmonary Disease • Respiratory Diseases