[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07527117":3,"trial-entities:NCT07527117":84,"trial-summary:NCT07527117":88},{"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":20,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":38,"secondary_outcomes":43,"sex":44,"minimum_age":45,"maximum_age":16,"healthy_volunteers":14,"eligibility_criteria":46,"std_ages":50,"locations":53,"central_contacts":77,"overall_officials":81,"references":82,"see_also_links":83},"NCT07527117","2026P000652","Role of n On-contrast Chest CT (NCCT) Based CT V: Q in Patients With Acute Pulmonary Embolism (aPE)","RECRUITING","2028-12-31","2026-09","2026-09-11","2026-07-15","Massachusetts General Hospital","OTHER",false,"We are doing the research to see if a CT scan without the dye can help find pulmonary emboli. If you agree to join the study, you will be asked to sign this consent form before we do any research procedures. If you join the research, we will ask you to blow into a small device known as a spirometer to train you to hold your breath after you inhale and exhale. Spirometer is a small handheld device to find out how well your lungs work when you inhale and exhale. For this research, we will obtain two extra sets of CT images at very low levels of radiation dose. The two extra sets of images will take less than 1 minute. Your total participation time is about 5 minutes. We will also review your medical record for up to 30 to 90 days after your CT scan.\n\nThe main risks of being in the study are exposure to ionizing radiation which may have health risks, and minor inconvenience from the spirometer test.\n\nYou will not benefit from taking part in this research study. If you take part in this study, your participation may help people in the future. If you decide not to be in the study, you will still have the standard-of-care chest CT with the dye ordered by your doctor. You will not be paid for taking part in this research study.",null,[18,19],"Pulmonary Embolism (Diagnosis)","Pulmonary Embolism Acute",[21],"CT ventilation perfusion pulmonary embolism CT pulmonary angiogram","INTERVENTIONAL","DIAGNOSTIC",[25],"NA",{"count":27,"type":28},750,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":36},"DIAGNOSTIC_TEST","Additional CT acquisition at low dose (1- 2 mSv)","In addition to their CTPA, we will acquire low-dose CT images in inspiration and expiration breath hold or in free breathing phase.",[35],"Non-contrast CT for diagnosis of acute pulmonary embolism",[37],"CT",[39],{"measure":40,"description":41,"timeFrame":42},"NPV for ruling out PE on non-contrast CT","Negative predictive value","2 years",[],"ALL","21 Years",{"inclusion":47,"exclusion":48,"raw_text":49},[],[],"Inclusion Criteria:\n\n1. Patients undergoing CTPA for suspected aPE\n2. Patients who provide written informed consent to participate\n3. Adults patients \\>\u002F= 21 years of age\n4. Mini Mental State Exam (MMSE) score of 18 or more.\n\nExclusion Criteria:\n\n1. Patients who decline informed consent\n2. Patients with known chronic PE\n3. Patients with known interstitial lung diseases\n4. Patients who cannot raise their arms above their shoulders (arms can cause serious artifacts)\n5. Women of child-bearing potential (\\\u003C 55 years) who test positive for pregnancy test\n6. Patients \\\u003C 21 years of age (to avoid research radiation dose in young patients)\n7. Patients with any EMR documented cognitive impairment or diseases such as dementia, recent head injury, psychiatric disorders, or other neurological diseases that impair decision-making.\n8. Pregnant subjects\n9. Women of child-bearing potential (21-55 years) who refuse to take a urine pregnancy test prior to their CT examination\n10. Mini Mental State Exam (MMSE) score of less than 18.",[51,52],"ADULT","OLDER_ADULT",[54,69],{"facility":55,"status":7,"city":56,"state":57,"zip":58,"country":59,"contacts":60,"geoPoint":66},"Massachusetts General Hospital\u002FHarvard Medical School","Boston","Massachusetts","02420","United States",[61],{"name":62,"role":63,"phone":64,"email":65},"MANNUDEEP K KALRA, MD","CONTACT","617-543-2623","mkalra@mgh.harvard.edu",{"lat":67,"lon":68},42.35843,-71.05977,{"facility":12,"status":70,"city":56,"state":57,"zip":58,"country":59,"contacts":71,"geoPoint":76},"NOT_YET_RECRUITING",[72],{"name":73,"role":63,"phone":74,"email":75},"Shivangi JHA, MD MPH","617-643-4583","sjha7@mgh.harvard.edu",{"lat":67,"lon":68},[78],{"name":79,"role":63,"phone":80,"email":75},"Shivangi JHA, MD, MPH","16176434583",[],[],[],{"nct_id":4,"conditions":85,"biomarkers":87},[86],"Pulmonary Embolism",[],{"nct_id":4,"found":89,"summary":90,"prompt_version":100},true,{"design":91,"status":92,"heading":93,"summary":94,"follow_up":95,"word_count":96,"commitments":97,"compensation":98,"drugs_mentioned":99},"This is an interventional study planning to enroll 750 participants. It is not specified if it is randomized or blinded.","completed","Investigating Non-Contrast CT for Pulmonary Embolism","This study is looking into whether a special type of CT scan, called a non-contrast chest CT (NCCT), can help find acute pulmonary embolism (blood clots in the lungs) without needing an injected dye. If you join, you'll have two extra, very low-dose CT scans that take less than a minute, in addition to your regular CT scan. You'll also be trained to hold your breath using a spirometer (a device to measure lung function). The study is for adults aged 21 and older who are already getting a CT scan for suspected pulmonary embolism. The main goal is to see how well the non-contrast CT can rule out pulmonary embolism, with results being checked up to two years later. The current recruitment status is unclear.","Your medical records will be reviewed for up to 30 to 90 days after your CT scan. The primary endpoint for ruling out PE on non-contrast CT is measured at 2 years.",126,"You will have two extra, low-dose CT scans and be trained to use a spirometer. Your total participation time is about 5 minutes, and your medical records will be reviewed for 30 to 90 days after your CT scan.","Not stated in the trial record.",[],"v2"]