[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"contrast-media\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:contrast-media":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,57,88],{"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":73,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":87},"100590313","study-on-sex-specific-individualized-dose-calculation-of-contrast-agent-in-ct-examinations-100590313","NCT06965790","Study on Sex-specific, Individualized Dose Calculation of Contrast Agent in CT Examinations","Randomized Controlled Study on Sex-specific, Individualized Dose Calculation of Intravenously Administered Contrast Agent in CT Examinations in Portal Venous Phase to Achieve Equivalent Contrast in Men and Women","Inclusion Criteria:\n\n* Presence of a justifying indication for a CT scan of the thorax and abdomen with application of intravenous contrast medium and a start delay corresponding to the portal venous contrast medium phase\n* Ability to give informed consent, as well as written and verbal consent to participate in the study available\n\nExclusion Criteria:\n\n* Cardiorespiratory instability (as assessed by the attending physician)\n* Age \\\u003C18 years\n* Existing or suspected pregnancy\n* Known post hepatectomy and\u002For splenectomy\n* Lack of current height (in the same inpatient\u002Foutpatient hospital stay) or lack of possibility of height measurement\n* Lack of current daily body weight or inability to measure body weight\n* Height under 140 cm or over 220 cm\n* Body weight under 50 kg or over 120 kg\n* Contraindication to iodine-containing contrast medium (Allergy to contrast media containing iodine, Severe renal insufficiency (eGFR \\\u003C 30 ml\u002Fmin), Hyperthyroidism)",{"count":65,"type":22},400,[67],"NA","A large proportion of radiological CT examinations require the intravenous administration of iodine-containing X-ray contrast medium. According to current guidelines, the amount required for CT examinations in the (portal) venous phase is calculated on the basis of body weight (e.g. 0.2-0.4 g iodine\u002Fkg body weight), but a standardized application dose of the contrast agent is often also used.\n\nIn earlier studies, the investigators found that the iodine contrast in vessels and organs achieved with a standardized amount of contrast agent differs significantly between women and men. On average, women showed around 10% higher iodine contrast than men of the same height and weight. The investigators attribute these differences to physiological, sex-specific differences in blood volume. For example, the blood volume of a woman 175 cm tall and weighing 75 kg is approx. 400 ml less than that of a man of the same height and weight (approx. 4.6 vs. 5.0 l, calculated according to Nadler). Taking blood volume into account, sex was no longer a significant influencing factor in a retrospective cohort (n=274).\n\nThe investigators would now like to investigate these results in a prospective study. For this purpose, two groups of patients with a clinical indication for a contrast-enhanced CT scan in the venous phase will be compared:\n\n1. control group with regular weight-adjusted (n = 200)\n2. study group with dosing according to blood volume (n = 200).\n\nThe hypothesis is that the application scheme adapted to the blood volume leads to a more homogeneous contrasting of women and men. In order to quantify this effect, the iodine contrast values of both groups will be quantitatively analyzed, taking into account other influencing variables (height, weight).\n\nThe investigators hope that this approach will reduce or even eliminate the observed sex-specific differences. This would lead to a sex-equal contrast based on an individualized amount of contrast medium.",[70,30,71,72],"CT Scans","Gender","Womens Health",[74,70,30,75,76],"CT","contrast","gender","2025-12-07",{"date":79,"type":48},"2025-12-09",{"date":81,"type":48},"2025-04-01",{"date":83,"type":22},"2027-03",{"name":85,"class":86},"University Hospital Augsburg","OTHER",1,{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":23,"phases":96,"briefSummary":97,"conditions":98,"keywords":101,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":87},"100583703","optimization-of-patient-preparation-and-imaging-techniques-for-cardiac-ct-100583703","NCT06879769","Optimization of Patient Preparation and Imaging Techniques for Cardiac CT","Inclusion Criteria:\n\n* Participant with a preexisting referral for a Cardiac CT examination\n* Age 18 years or older\n\nExclusion Criteria:\n\n* Age under 18 years\n* Atrial fibrillation\n* Pacemaker\n* Participation in clinical drug trials\n* Contraindications to beta-blockers\n* Severe medical conditions\n* Challenges in comprehending study information\n* Pregnancy",{"count":95,"type":22},240,[67],"The goal of this clinical trial is to compare four different methods of reducing heart rate before cardiac imaging. The diagnostic imaging technique used in this study is called Computed Tomography (CT) of the coronary vessels (CCTA). Globally, approximately one-third of patients experience heart-related conditions. Because the heart is a moving organ, imaging presents challenges. A higher heart rate requires increased scanning power, which results in more images and, in some cases, higher radiation exposure that may be harmful. To address this issue, beta-blocker medication is administered before the examination to lower the heart rate. This medication can be given orally, intravenously, or both. While this approach is effective, the most optimal method remains uncertain.\n\nThe objectives of this study are:\n\n* To determine whether oral administration of beta-blockers is as effective as intravenous administration in maintaining a stable heart rate during CT imaging.\n* To assess whether listening to music during the procedure improves patient comfort and overall experience.\n\nParticipants will:\n\n* Be randomly assigned to one of four groups:\n* One group will receive beta-blocker medication orally.\n* Another group will receive beta-blocker medication intravenously.\n* One group will listen to music during the procedure. Participants will report their sensations and experiences before, during, and after the examination.\n\nThe study investigators will compare the effectiveness of oral and intravenous beta-blockers, as well as the impact of music, in terms of:\n\n* Heart rate stability and reduction.\n* Participant-reported comfort and overall experience.",[99,30,100],"Coronary Computed Tomography Angiography","Cardiac Output",[102,100,103,104,105],"Music intervention","CCTA","Beta blockers","Metoprolol","2025-03-14",{"date":108,"type":48},"2025-03-17",{"date":110,"type":48},"2021-01-01",{"date":112,"type":22},"2027-12-01",{"name":114,"class":86},"Karolinska University Hospital"]