[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05215132":3,"trial-entities:NCT05215132":91,"trial-summary:NCT05215132":95},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":44,"secondary_outcomes":49,"sex":53,"minimum_age":54,"maximum_age":55,"healthy_volunteers":56,"eligibility_criteria":57,"std_ages":74,"locations":77,"central_contacts":87,"overall_officials":88,"references":89,"see_also_links":90},"NCT05215132","STU#00211312","Investigational MRI Clinical Software and Hardware","Study Evaluation of Feasibility and Reproducibility of Investigational MRI Clinical Software","ACTIVE_NOT_RECRUITING","2028-01-31","2026-09","2026-09-15","2019-12-19","Northwestern University","OTHER",false,"Patients and healthy volunteers will be scanned in order to test new sequences.","The aims of this study are to:\n\n1. Conduct clinical protocol development and validation: The settings of an MRI machine are commonly adjusted according to the body part being scanned and the reason for the exam. When testing out new sequences and settings or adjusting existing settings, human subjects (patients and healthy volunteers) may be scanned in order to make sure that the quality of the images produced by the MRI machine is adequate for diagnostic purposes and to obtain normative values.\n2. Demonstrate and train: In some cases, human subjects may be scanned for the purposes of demonstrating equipment or for training operators on the safe and effective use of MRI systems.",[19],"Image, Body",[21],"MRI hardware testing","INTERVENTIONAL","DIAGNOSTIC",[25],"PHASE4",{"count":27,"type":28},2000,"ESTIMATED",[30,39],{"type":31,"name":32,"description":33,"armGroupLabels":34},"RADIATION","MRI","1.5T or 3T MRI scanner (Siemens Medical Systems)",[35,36,37,38],"Patient no contrast","Patient w\u002F Contrast","Volunteer no contrast","Volunteer w\u002F contrast",{"type":40,"name":41,"description":42,"armGroupLabels":43},"DRUG","Gadavist 2Ml Solution for Injection","Arm 1 and Arm 3 subjects will undergo this intervention (Gadavist 2Ml solution)",[36,38],[45],{"measure":46,"description":47,"timeFrame":48},"Conduct clinical protocol development and validation","Testing of new MRI pulse sequences will be performed for validation of potential new diagnostic capabilities. The MRI pulse sequences will be routinely performed along with clinically-validated and accepted pulse sequences for comparison of the novel sequences in human subjects (patients and healthy volunteers). Novel sequences will be performed in the accepted method with adjustment of settings to evaluate image qualities and normative values produced by the MRI machine. The resulting images provided by the novel sequences will be able to evaluated for diagnostic quality and to obtain comparison of possible improvements alongside clinically-validated MRI pulse sequences.","5 years",[50],{"measure":51,"description":52,"timeFrame":48},"Demonstrate and train","Human subjects may be scanned utilizing MRI pulse sequences in the context of a clinical assessment for demonstrating of equipment or sequence function for training of MRI technologist. The sequence will be performed by a skilled technologist with the primary goal of providing information on proper utilizing of MRI hardware and software for technologist who are training and will be possibly utilizing these technique to provided safe and effective use of MRI systems and their software.","ALL","18 Years","90 Years",true,{"inclusion":58,"exclusion":64,"raw_text":73},[59,60,61,62,63],"• At least 18 years of age","Able to complete the MR safety questionnaire.","Able to comprehend and provide informed consent in English.","When contrast is being administered: healthy volunteers with a GFR≥60 ml\u002Fmin","When contrast is being administered: patients with a GFR ≥30 ml\u002Fmin",[65,66,67,68,69,70,71,72],"• When contrast is being administered: subjects with a GFR \\\u003C 30 ml\u002Fmin","When contrast is being administered: subjects with acute kidney injury","When contrast is administered, allergy to gadolinium-containing contrast media","Contraindication to MRI (implanted device, claustrophobia, dyspnea precluding the ability to follow breath-hold instructions)","Adults unable to consent","Individuals who are not yet adults","Pregnant or breastfeeding women","Prisoners","Inclusion Criteria:\n\n* • At least 18 years of age\n\n  * Able to complete the MR safety questionnaire.\n  * Able to comprehend and provide informed consent in English.\n  * When contrast is being administered: healthy volunteers with a GFR≥60 ml\u002Fmin\n  * When contrast is being administered: patients with a GFR ≥30 ml\u002Fmin\n\nExclusion Criteria:\n\n* • When contrast is being administered: subjects with a GFR \\\u003C 30 ml\u002Fmin\n\n  * When contrast is being administered: subjects with acute kidney injury\n  * When contrast is administered, allergy to gadolinium-containing contrast media\n  * Contraindication to MRI (implanted device, claustrophobia, dyspnea precluding the ability to follow breath-hold instructions)\n  * Adults unable to consent\n  * Individuals who are not yet adults\n  * Pregnant or breastfeeding women\n  * Prisoners",[75,76],"ADULT","OLDER_ADULT",[78],{"facility":79,"city":80,"state":81,"zip":82,"country":83,"geoPoint":84},"Northwestern University- Feinberg School of Medicine","Chicago","Illinois","60611","United States",{"lat":85,"lon":86},41.85003,-87.65005,[],[],[],[],{"nct_id":4,"conditions":92,"biomarkers":94},[93],"Healthy Volunteers",[],{"nct_id":4,"found":56,"summary":96,"prompt_version":106},{"design":97,"status":98,"heading":99,"summary":100,"follow_up":101,"word_count":102,"commitments":103,"compensation":104,"drugs_mentioned":105},"This is an interventional study planning to enroll up to 2000 participants. It involves testing different MRI settings and, for some, receiving a contrast agent.","completed","Investigational MRI Clinical Software and Hardware Study","This study is testing new software and hardware for MRI (Magnetic Resonance Imaging) machines. Researchers want to make sure the images produced by the MRI are good enough for doctors to use for diagnosis. Some participants will receive Gadavist 2Ml Solution for Injection, a contrast agent used to improve MRI images. This study is open to healthy volunteers and patients aged 18 to 90. If you receive Gadavist, you must have healthy kidney function (GFR ≥60 ml\u002Fmin for healthy volunteers, or GFR ≥30 ml\u002Fmin for patients). The main goal is to develop and confirm the usefulness of these new MRI settings over 5 years. The current recruitment status is unclear.","The primary endpoint for the study is measured at 5 years, but it's not specified if this refers to individual participant follow-up.",110,"You would undergo MRI scans. If contrast is administered, you would receive Gadavist 2Ml Solution for Injection. The record does not specify the number of visits or the total duration of your participation.","Not stated in the trial record.",[32,41],"v2"]