Dotarem (gadoterate meglumine) / Guerbet - LARVOL DELTA

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

Dotarem Evaluation for Myocardial Perfusion CMR (clinicaltrials.gov) - P=N/A | N=90 | Completed | Sponsor: Medical University of South Carolina | Recruiting ➔ Completed

Trial completion

Confounded Magnetic Resonance Imaging Contrast Agent Exposures and Gadolinium Retention in Organs (KIDNEY WEEK 2024) - "There are two general classes of GBCAs: linear (e.g., Omniscan) and macrocyclic (Dotarem)... Gadolinium is retained in the heart and lung for linear, macrocyclic, and confounded agent exposure. Adipose retains macrocyclic agents. Skeletal muscle retains linear agents."

MRI • CNS Disorders • Fibrosis • Immunology • Renal Disease

Curcumin Coated Ultra-Small Iron Oxide Nanoparticles as T1 Contrast Agents for Magnetic Resonance Imaging of Cancer Cells. (PubMed, J Biomed Phys Eng) - "Fe3O4@C nanoparticles (NPs) are good at imaging; based on a relaxometry test, the r1 and r2 relaxivities of Dotarem were 3.139 and 0.603 mM-1s-1, respectively...The NPs can be identified as a positive contrast agent with a weight of T1 in MRI. The coresh-ell Fe3O4@C NPs can be effective in cancer treatment and diagnosis because of the therapeutic effects of curcumin and the properties of USPIO."

Journal • MRI • Colon Cancer • Colorectal Cancer • Oncology • Solid Tumor

Unique Cardiac MRI Tissue Characteristics In Testosterone-associated Cardiomyopathy (HFSA 2024) - "Cardiac MRI with and without Gadolinium contrast (Dotarem) was performed using a Philips Achieva 1.5T scanner to evaluate different parameters...Cardiac MRI with and without Gadolinium contrast (Dotarem) was performed using a Philips Achieva 1.5T scanner to evaluate different parameters... Patients with cardiomyopathy and concomitant use of testosterone demonstrated a normal to mildly dilated LV volume on cardiac MRI. The notable reduction in ECV is likely attributable to decreased interstitial space resulting from myocyte hypertrophy and testosterone-associated polycythemia. Possibly, mildly dilated LV volume along with an elevated ECV and reduced LVEF suggest a later stage of testosterone-induced cardiomyopathy characterized by interstitial fibrosis."

Cardiomyopathy • Cardiovascular • Congestive Heart Failure • Fibrosis • Heart Failure • Immunology

Different rates and patterns of symptoms associated with gadolinium exposure among gadolinium-based contrast agents. (ESUR 2024) - "• To ensure the comparability of the data, three macrocyclic GBCAs, namely gadoteridol (Prohance®, Bracco), gadobutrol (Gadovist®/Gadavist®, Bayer Healthcare), gadoterate meglumine (Dotarem®, Guerbet; Clariscan®, GE Healthcare), and three linear (open chain) GBCAs, namely gadobenate dimeglumine (Multihance®, Bracco), gadodiamide (Omniscan®, GE) and gadopentetate dimeglumine (Magnevist®, Bayer Healthcare) were selected, Figure 1...• A causal relationship could not be established between SAGE and the corresponding GBCAs, therefore, further research on this topic and routine pharmacovigilance are warranted. Refrerences: † CE-MRI: contrast-enhanced magnetic resonance imaging; FDA: food and drug authority."

CNS Disorders • Fibrosis • Immunology • Mental Retardation • Musculoskeletal Diseases • Psychiatry • Rheumatology

Advanced testicular ultrasound and Magnetic Resonnnance imaging in male patients with extragonadal germ cell tumor (ESUR 2024) - "The imaging protocol included the following sequences: axial T1 turbo spin echo (TSE) with a slice thickness of 2.5mm, axial, coronal, and sagittal T2 TSE with a slice thickness of 2.5mm, axial diffusion with two b-values (50-1000) and calculation of the apparent diffusion coefficient (ADC), axial T1 FS TSE in dynamic acquisition (seven consecutive imaging sets, each with an acquisition time of 60 seconds) acquired immediately after manual administration of Gadolinium (Dotarem) then late axial T1 after injection...In the case of pure mediastinal seminoma, tumors may be considered truly extragonadal. In these cases, it might be reasonable to recommend at least ultrasound looking for microlithiasis."

Clinical • Metastases • Genetic Disorders • Germ Cell Tumors • Infertility • Oncology • Pain • Psychiatry • Sexual Disorders • Testicular Cancer • Testicular Seminoma

Localization of concordant and discordant PSMA positive lesions on prostate MRI with PI-RADS 3 (ESUR 2024) - "The following image sequences were at least acquired: (i) transverse T2 weighted fast spin echo without fat saturation (FS), (ii) transverse fat-suppressed single-shot echo-planar diffusion weighted image (DWI) with at least two b values, and (iii) time-resolved dynamic contrast enhancement (DCE) transverse T1-weighted spoiled gradient echo without FS before and after administration of contrast agents (Dotarem, Guerbet)...Our study also showed that 40% of patients with PI-RADS 3 had discordant PSMA-positive lesions outside PI-RADS 3 lesions. Discordant PSMA-positive lesions with higher SUV max than that of PI-RADS 3 lesions often represented another more aggressive focus not initially identified on MRI."

Discordant • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Differences in hypersensitivity reactions and gadolinium deposition disease/symptoms associated with gadolinium exposure to gadolinium-based contrast agents: new insights based on global databases VigiBase, FAERS, and IQVIA-MIDAS. (PubMed, BMC Med) - "The risk differences among GBCAs using data from several sources were compared in this study. However, as a hypothesis-generating method, a clear causal relationship would require further research and validation."

Journal • Cardiovascular • Immunology

Gadolinium Retention in Human Bone Tissue in Pediatric Patients (clinicaltrials.gov) - P=N/A | N=60 | Recruiting | Sponsor: Donna Roberts | Trial primary completion date: Jun 2024 ➔ Aug 2024

Trial primary completion date • Pediatrics

Collagen-targeted PET Imaging for Early Interstitial Lung Disease (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Massachusetts General Hospital | Trial completion date: Apr 2024 ➔ Apr 2025 | Trial primary completion date: Apr 2024 ➔ Apr 2025

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

Deposition of Gadolinium in the Central and Peripheral Nervous Systems and Its Effects on Sensory, Cognitive, and Athletic Implications after Multiple Injections of Gadolinium-Based Contrast Agents in Rats. (PubMed, AJNR Am J Neuroradiol) - "Multiple injections of GBCAs caused gadolinium deposition in the brain, spinal cord, and peripheral nerves, especially in the spinal cords of the gadodiamide group. Gadodiamide led to pain hypersensitivity and decreased muscle power and cognitive ability. For the patients who are hypersensitive to pain and need multiple MRI examinations, we recommend using macrocyclic GBCAs and the lowest dose possible."

Journal • Preclinical • Immunology • Pain • GFAP

Diffusion -and Perfusion Weighted MRI for Response Prediction of Symptomatic Leiomyomas Following Uterine Artery Embolization (clinicaltrials.gov) - P=N/A | N=100 | Active, not recruiting | Sponsor: Universitaire Ziekenhuizen KU Leuven | Unknown status ➔ Active, not recruiting | Trial completion date: Dec 2016 ➔ Dec 2025 | Trial primary completion date: Dec 2015 ➔ Dec 2025

Enrollment closed • Trial completion date • Trial primary completion date • Solid Tumor