[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Guerbet\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":85},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,57],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":56},"100391175","phase-4-effect-on-body-movement-and-mental-skills-in-patients-who-received-gadolinium-based-contrast-media-for-magnetic-resonance-examination-multiple-times-within-5-years-100391175",false,"NCT04373564","Effect on Body Movement and Mental Skills in Patients Who Received Gadolinium-based Contrast Media for Magnetic Resonance Examination Multiple Times Within 5 Years","Prospective Evaluation of Potential Effects of Repeated Gadolinium-based Contrast Agent (GBCA) Administrations of the Same GBCA on Motor and Cognitive Functions in Neurologically Normal Adults in Comparison to a Non-GBCA Exposed Control Group","ODYSSEY","Inclusion Criteria:\n\n* Participant must be neurologically normal, defined as free of unstable neurologic and psychiatric disease as confirmed by a normal neurologic examination at screening\n* Participant (GBCA-exposed or controls) agrees to undergo unenhanced magnetic resonance imaging (UE-MRI) of the brain at enrollment and at the end of the observation period (5 years)\n* Participants should have at least 1 of the following indications: a) Medium to high risk for breast cancer or dense breasts undergoing breast cancer screening with MRI, b) Elevated prostate-specific antigen (PSA) and under active diagnostic surveillance for prostate cancer, c) Chronic liver disease (eg, liver cirrhosis limited to Child class A, post-hepatitis chronic hepatopathy, or primary sclerosing cholangitis) for surveillance of hepatocellular carcinoma development, d) Low-grade colorectal cancer or neuroendocrine tumor undergoing screening for liver metastases or e) Branch-duct intraductal papillary mucinous neoplasm (IPMN) of the pancreas (maximum size ≤2 cm) undergoing imaging surveillance.\n\nIn addition, for participants in the GBCA Arms only:\n\n* Each participant should be likely to undergo ≥5 GBCA-enhanced MR examinations with the same GBCA at least annually throughout the 5-year study duration\n* Prospective participants with up to 3 well documented GBCA administrations prior to study screening are acceptable, provided that the imaging was performed with the same GBCA as the one to be prospectively used in the study. If the GBCA used cannot be identified, he\u002Fshe cannot be enrolled.\n\nFor the Control Arm:\n\n* Participants who never had and are not likely to receive any GBCA injection during the course of the study\n* Each control participant must be willing to undergo UE-MRI of the brain at baseline and at Year 5. In Years 1 to 4, the control participants will undergo their clinically indicated UE-MRIs, computed tomography (CT), ultrasound, or X-ray procedures\n\nExclusion Criteria:\n\n* As evidenced by history or determined in the neurologic exam at screening, concurrent neurological and\u002For psychiatric disease (or treatments) that could influence the results of the study's motor and cognitive tests (e.g. Cerebrovascular disease, Multiple sclerosis, Neurodegenerative disease, Malignant disease other than listed in indications, Carcinoid tumors, Epilepsy, Prior neurosurgery, Psychotic disorders or any prior psychotic episode not otherwise specified - any documented prior history of chronic schizophrenia, Remittent or current medically confirmed major depressive disorder or bipolar disorder, History of long-term major depression or bipolar affective disorder with an active episode in the past 2 to 5 years, Neurodevelopmental disorders (eg, trisomy 21), Uncontrolled severe migraine, Uncontrolled or controlled anxiety or depression within 6 months before enrollment, Screening scores of ≤24 on the MMSE and\u002For ≥11 on the Hospital Anxiety and Depression Scale (HADS)).\n* Prior, planned, or ongoing chemotherapy or brain irradiation\n* Use of concomitant medication(s) affecting neuro-cognitive or motor function\n* Substance or alcohol abuse as determined by the investigator\n* Alcoholic cirrhosis\n* Renal disease, defined as estimated glomerular filtration rate (eGFR) \\\u003C 60 mL\u002Fmin\u002F1.73 m2\n* History of environmental\u002Foccupational\u002Fother exposure to one or more chemicals that may affect cognitive and\u002For motor function, including, but not limited to, heavy metals (arsenic \\[As\\], cadmium \\[Cd\\], lead \\[Pb\\], manganese \\[Mn\\], and mercury \\[Hg\\]), pesticides, solvents, or carbon monoxide.\n* Clinical indications requiring \\>1 contrast enhanced magnetic resonance imaging (CE-MRI) every 6 months\n* Pregnant or nursing (lactating) women\n* Presence of any metal-containing joint implants\u002Fprostheses\n\nIn addition, for participants in either of the GBCA Arms only:\n\n\\- Receipt of a GBCA or generic prior to study entry other than the specific GBCA to be administered during the course of the study.\n\nFor participants in the Control Arm only:\n\n* Participants with any previous exposure to a GBCA.\n* Participants with any contraindication to UE-MRI examinations.","ALL","18 Years","64 Years",{"count":21,"type":22},2076,"ESTIMATED","INTERVENTIONAL",[25],"PHASE4","This study is a postmarketing requirement jointly carried out by four NDA holders (Bayer AG, Bracco, GE Healthcare and Guerbet) and the CRO IQVIA.\n\nThe study aims to create detailed images of the organs and tissue of the human body during x-ray, CT-scan or MRI investigations, doctors are using contrast media (a kind of dye) which can be given to patients by injection into a blood vessel or by mouth.\n\nIn this study researchers want to find out whether so called gadolinium-based contrast agents (GBCAs) have an effect on body movement and mental skills when given to participants multiple times within 5 years.\n\nThe study plans to enroll about 2076 participants suffering from a condition for which they are likely to have at least annually a MRI or another imaging examinations. Only adults up to 65 years will be considered to join this study. During the study duration of 5 years participants will receive annually a MRI or other imaging tests (such as CT-scan, x-ray) and will visit the study doctor at least 7 times for physical examinations, laboratory investigations and tests on body movement and mental skills.",[28,29,30],"Motor Function","Cognitive Function","Contrast Media",[32,33,34,35,36,37,38,39,40,41,42,43],"Motor function assessment","Cognitive function assessment","Magnetic Resonance Imaging (MRI)","Gadolinium","Gadolinium-based contrast agent (GBCA)","Gadolinium retention","Breast cancer","Prostate cancer","Hepatocellular carcinoma","Colorectal cancer","Neuroendocrine tumor","Branch-duct intraductal papillary mucinous neoplasm (IPMN) of the pancreas","RECRUITING","2026-01-21",{"date":47,"type":48},"2026-01-22","ACTUAL",{"date":50,"type":48},"2021-03-24",{"date":52,"type":22},"2028-12-31",{"name":54,"class":55},"Guerbet","INDUSTRY",51,{"id":58,"slug":59,"hasResults":11,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":4,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":64,"targetDuration":4,"studyType":23,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},"100619747","phase-3-evaluation-of-the-efficacy-and-safety-of-magnetic-resonance-angiography-mra-using-gadopiclenol-compared-to-gadoterate-meglumine-in-the-assessment-of-steno-occlusive-disease-in-adult-patients-with-suspected-vascular-disease-100619747","NCT07348640","Evaluation of the Efficacy and Safety of Magnetic Resonance Angiography (MRA) Using Gadopiclenol Compared to Gadoterate Meglumine in the Assessment of Steno-occlusive Disease in Adult Patients With Suspected Vascular Disease","A Prospective, Multi-National, Randomized, Double-Blind, Crossover Study to Evaluate the Efficacy and Safety of Gadopiclenol-enhanced MRA Compared to Gadoterate Meglumine-enhanced MRA in the Assessment of Steno-occlusive Disease in Adult Patients With Suspected Vascular Disease","Inclusion Criteria:\n\n1. Male or female patients 18 years of age or older willing to participate in the trial and follow all study procedures specified in the protocol.\n2. Patient having read the information in the ICF and having provided his\u002Fher consent to participate in writing by dating and signing the ICF prior to any trial related procedure being conducted.\n3. Patient with suspected steno-occlusive disease in supra-aortic (carotid\u002Fvertebrobasilar) (a), peripheral (b) or abdominal\u002Frenal (c) arteries based on:\n\n   1. clinical signs and symptoms including but not limited to prior stroke, transient ischemic attack (TIA), amaurosis fugax (transient monocular blindness) and\u002For previous diagnostic tests (CTA, IA-DSA, or ultrasound) or\n   2. symptoms of lower-extremity arterial disease (stages II-IV according to the Leriche-Fontaine classification, or 1 to 6 according to Rutherford classification 113 and\u002For confirmed by previous imaging (Doppler ultrasound, CTA, MRA, IADSA) or\n   3. suspected renovascular hypertension based on one or more of the following criteria:\n\n   i. hypertension refractory to standard therapy ii. acute worsening of pre-existing hypertension iii. abrupt onset of sustained, moderate to severe hypertension at age \\\u003C35 years suggestive of fibromuscular dysplasia (FMD) iv. progressive renal insufficiency (creatinine \\> 2 mg\u002FdL; no other apparent cause of progressive renal failure based on routine medical history, physical examination, 24-h urine collection and urinary protein excretion) v. abnormal\u002Finconclusive renal doppler ultrasound. vi. other criteria (to be specified)\n4. Are scheduled for or had undergone CTA and\u002For IA-DSA according to imaging standards to cover the supra-aortic (carotid\u002Fvertebrobasilar) and\u002For peripheral and\u002For abdominal\u002Frenal territory described in this protocol.\n\nExclusion Criteria:\n\n1. Is a pregnant or lactating female. Exclude the possibility of pregnancy for women of childbearing potential:\n\n   * by testing on site at the institution (serum βHCG or urine)\n   * by surgical history (e.g., tubal ligation or hysterectomy)\n   * post-menopausal with a minimum 1 year without menses.\n2. Has any known allergy to one or more of the ingredients in the investigational products or has a history of hypersensitivity to other GBCAs.\n3. Has severe renal impairment defined as an estimated glomerular filtration rate (eGFR) below 30 mL\u002Fmin\u002F1.73 m2 calculated using the Modification of Diet in Renal Disease (MDRD) formula.\n4. Has known or suspected acute kidney injury (AKI) based on: a. Increase in serum creatinine by ≥ 0.3 mg\u002FdL (≥ 26.5 μmol\u002FL) within 48 hours or b. Increase in serum creatinine to ≥ 1.5 times baseline, which is known or presumed to have occurred within prior 7 days or c. Urine volume \\\u003C 0.5 mL\u002Fkg\u002Fh for 6 hours\n5. Has received any contrast agent (for MRI, CT, DSA) prior to the first IMP administration or is scheduled to receive any contrast agent between the two MRA or after the second IMP administration.\n6. Has received or is scheduled for therapeutic intervention (e.g., endovascular therapy, vascular surgery, etc.) of any kind for vascular disease in the arterial territory of interest performed between the 2 MRA procedures or between the study MRAs and the CTA\u002FIADSA procedures when applicable.\n7. Has any contraindications to MRI.\n8. Is suffering from severe claustrophobia.\n9. Has received an investigational drug or medical device before admission into this study or scheduled to receive any investigational treatment in the course of the trial.\n10. Was previously included in this trial.\n11. Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and\u002For post-dose follow-up examinations.",{"count":65,"type":22},315,[67],"PHASE3","Compare the diagnostic performance of gadopiclenol against gadoterate meglumine in patients with vascular diseases of supra-aortic, peripheral, or abdominal \u002F renal arteries using MRI",[70],"Steno-occlusive Disease",[72,73,74],"steno-occlusive disease","gadopiclenol","Magnetic Resonnance Angiography","NOT_YET_RECRUITING","2026-01-16",{"date":78,"type":48},"2026-01-20",{"date":80,"type":22},"2026-02-02",{"date":82,"type":22},"2027-12-31",{"name":54,"class":55},41,""]