[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07661706":3,"trial-entities:NCT07661706":91,"trial-summary:NCT07661706":95},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":23,"interventions":26,"primary_outcomes":32,"secondary_outcomes":37,"sex":41,"minimum_age":42,"maximum_age":21,"healthy_volunteers":43,"eligibility_criteria":44,"std_ages":58,"locations":61,"central_contacts":80,"overall_officials":85,"references":89,"see_also_links":90},"NCT07661706","SA-000043","Data Collection of New Spectral CT Imaging Method","RECRUITING","2026-08","2026-06","2026-06-22","2025-12-19","GE Healthcare","INDUSTRY",false,"The purpose of the study is to collect data to evaluate utility of a next generation spectral CT system in a clinical setting.","Data collected in this study includes an assessment of image quality parameters to evaluate the product. This data and analysis will help support regulatory submissions.",[18],"Computed Tomography",[],"OBSERVATIONAL",null,[],{"count":24,"type":25},50,"ESTIMATED",[27],{"type":28,"name":29,"description":30,"armGroupLabels":31},"DEVICE","Research CT","Participants will undergo a research CT on an investigational Spectral CT Imaging scanner which will be matched to their prior or scheduled SOC CT. Scans will be matched on anatomy, radiation dose, and contrast administration.",[29],[33],{"measure":34,"description":35,"timeFrame":36},"Evaluable Raw Research Scans","Number of participants who research scan is deemed evaluable (i.e., no issues with participant motion or contrast administration\u002Ftiming)","Through study completion, an average of 1 year",[38],{"measure":39,"description":40,"timeFrame":36},"Safety Assessment","Number of Adverse Events and\u002For Serious Adverse Events reported.","ALL","18 Years",true,{"inclusion":45,"exclusion":49,"raw_text":57},[46,47,48],"Who are ≥18 years of age;","Able to sign and date the informed consent form; AND,","Who have in the past 90 days or will in the future 30 days of the investigational scan undergo a clinically indicated CT exam within the St. Luke's University Hospital Network of the neck, chest, abdomen, pelvis, or extremities.",[50,51,52,53,54,55,56],"Who are pregnant or lactating;","Who were previously enrolled in this study;","For planned contrast-enhanced investigational CT exams, anyone with known or suspected allergy to iodinated contrast agents;","For planned contrast-enhanced investigational CT exams, anyone with known or suspected renal insufficiency as determined by site medical personnel;","Who need urgent or emergent care;","Who have any conditions that, in the opinion of the PI or designee, would interfere with the evaluation of the results or constitute a health hazard for the subject; OR,","Who are unwilling to have GEHC personnel present for the CT exam.","Inclusion Criteria:\n\n* Who are ≥18 years of age;\n* Able to sign and date the informed consent form; AND,\n* Who have in the past 90 days or will in the future 30 days of the investigational scan undergo a clinically indicated CT exam within the St. Luke's University Hospital Network of the neck, chest, abdomen, pelvis, or extremities.\n\nExclusion Criteria:\n\n* Who are pregnant or lactating;\n* Who were previously enrolled in this study;\n* For planned contrast-enhanced investigational CT exams, anyone with known or suspected allergy to iodinated contrast agents;\n* For planned contrast-enhanced investigational CT exams, anyone with known or suspected renal insufficiency as determined by site medical personnel;\n* Who need urgent or emergent care;\n* Who have any conditions that, in the opinion of the PI or designee, would interfere with the evaluation of the results or constitute a health hazard for the subject; OR,\n* Who are unwilling to have GEHC personnel present for the CT exam.",[59,60],"ADULT","OLDER_ADULT",[62],{"facility":63,"status":7,"city":64,"state":65,"zip":66,"country":67,"contacts":68,"geoPoint":77},"St Luke's University Health Network","Bethlehem","Pennsylvania","18015","United States",[69,74],{"name":70,"role":71,"phone":72,"email":73},"Monica Hosler","CONTACT","484-658-4567","monica.hosler@sluhn.org",{"name":75,"role":76},"Pallav N Shah, MD","PRINCIPAL_INVESTIGATOR",{"lat":78,"lon":79},40.62593,-75.37046,[81],{"name":82,"role":71,"phone":83,"email":84},"Melissa Challman, MPH, CCRP","18582213007","melissa.challman@gehealthcare.com",[86],{"name":87,"affiliation":12,"role":88},"Brian Thomsen","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":92,"biomarkers":94},[93],"Patients Undergoing Diagnostic Imaging",[],{"nct_id":4,"found":43,"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 observational study aiming to enroll 50 participants. It is designed to collect data on a new imaging method.","completed","Data Collection for New Spectral CT Imaging Method","This study is collecting data on a new type of imaging machine called a research CT (computed tomography) scanner. The goal is to see how well this investigational Spectral CT Imaging scanner works in a real-world medical setting. You might be able to join if you are 18 or older, can sign a consent form, and have had or will have a regular CT scan of your neck, chest, abdomen, pelvis, or extremities at St. Luke's University Hospital Network within a specific timeframe. The study will be considered successful if enough high-quality research scans are collected to help evaluate the new device. The current status of this study is unclear.","Data collection will continue through study completion, which is expected to be an average of 1 year.",110,"Participants will undergo one research CT scan on an investigational Spectral CT Imaging scanner. This scan will be matched to a prior or scheduled standard-of-care CT scan.","Not stated in the trial record.",[29],"v2"]