An interventional study of Low Dose CT scan in Respiratory Illness, sponsored by Northwestern University. Recruiting at 1 site in United States. Open to participants aged 21 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Northwestern University · Not applicable, Interventional, and Screening
Respiratory illnesses are a leading cause of morbidity and mortality worldwide, yet their prevalence in the general population remains poorly characterized. Computed tomography (CT) is the most effective diagnostic tool for identifying respiratory illnesses that cause changes to the lung parenchyma, such as pulmonary infections, fibrosis, and nodules. The diagnostic power of CT led the US Preventive Services Task Force (USPSTF) to issue lung cancer screening guidelines. In this prospective, observational cohort study, the study team will recruit 10,000 individuals aged 21 to 85 years, stratified into three cohorts: Cohort 1 (Medical Indication Group), Cohort 2 (Guideline-Based Screening Group), and Cohort 3 (Asymptomatic Research Low-Dose CT [LDCT] Group). The primary analysis will estimate the baseline cross-sectional prevalence of LDCT-detectable pulmonary findings in Cohort 3. Secondary analyses will compare baseline LDCT findings across all three cohorts and evaluate baseline associations between risk/exposure variables and CT findings. Exploratory follow-up analyses will use clinical data from the electronic health record (EHR), as available, for up to 5 years after the baseline/index CT. This study has the potential to transform health screening strategies, reduce disease burden, and improve health outcomes across diverse populations.
Northwestern University is the lead sponsor of 1,424 studies on the registry; 199 are open to participants now.
Of its 105 completed or terminated interventional studies of FDA-regulated products, 78 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
All Cohorts:
•Adults 21 through 85 years of age.
Cohort 1:
•Clinical indication for chest CT, such as suspected lung pathology, abnormal chest imaging, or pulmonary symptoms requiring further evaluation. Cohort 1 activities are routine clinical care; research activity is secondary data use.
Cohort 2:
•Individuals who currently meet USPSTF criteria for LDCT lung cancer screening. Cohort 2 activities are routine clinical care; research activity is secondary data use.
Cohort 3:
Exclusion Criteria:
All Cohorts:
•Individuals below the age of 21 and above the age of 85.
Cohort 3:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adults 21 through 85 years of age with a clinical reason for chest CT, such as suspected lung pathology, abnormal chest imaging, or pulmonary symptoms requiring further evaluation. Cohort 1 participants undergo CT and follow-up as part of routine clinical care. Study activity is limited to secondary use of routine-care data under waiver of consent and HIPAA authorization.
Adults 21 through 85 years of age who meet current USPSTF criteria for LDCT lung cancer screening. Cohort 2 participants undergo screening and follow-up as part of routine clinical care. Study activity is limited to secondary use of routine-care data under waiver of consent and HIPAA authorization.
Adults 21 through 85 years of age who are asymptomatic, do not have a clinical indication for chest CT, and do not meet current USPSTF lung cancer screening criteria. Cohort 3 participants will provide informed consent and HIPAA authorization before undergoing a single LDCT of the chest billed to the study.
Diagnostic Test: Low Dose CT scan
A low-dose CT scan is an X-ray procedure where a high-speed computer is used to make multiple images of your chest area using the least amount of radiation possible without reducing the diagnostic quality of the exam.
Also known as: LDCT
Primary Endpoint
Baseline prevalence of CT-detectable pulmonary abnormalities in Cohort 3.
Time frame: For each patient, routine turnaround of non-critical findings as reported by the radiologist, or up to 1 week.
Secondary Endpoint 1
Comparative baseline prevalence of pulmonary findings across Cohorts 1, 2, and 3.
Time frame: For each patient, routine turnaround of non-critical findings as reported by the radiologist, or up to 1 week.
Secondary Endpoint 2
Prevalence and reported severity of coronary artery calcification in Cohort 3 and across cohorts, using the final radiology report categories, such as absent/present or none/mild/moderate/severe when available.
Time frame: For each patient, routine turnaround of non-critical findings as reported by the radiologist, or up to 1 week.
Secondary Endpoint 3
Prevalence of bone-density-related abnormalities or vertebral compression fracture findings across all three cohorts using the final radiology report terminology.
Time frame: For each patient, routine turnaround of non-critical findings as reported by the radiologist, or up to 1 week.
Secondary Endpoint 4
Associations between baseline defined variables and LDCT-detectable findings.
Time frame: For each patient, routine turnaround of non-critical findings as reported by the radiologist, or up to 1 week.
Secondary Endpoint 5
EHR-derived outcomes for up to 5 years after baseline/index LDCT, including clinically documented diagnoses, additional imaging, procedures, treatments, and mortality as available.
Time frame: 5 years
Exploratory Endpoint 1
Subgroup analyses by age, sex, race/ethnicity, smoking status, and exposure categories.
Time frame: 6 years
Exploratory Endpoint 2
Exploratory prediction models if event counts support model development.
Time frame: 6 years
Exploratory Endpoint 3
Descriptive analyses of downstream clinical evaluation after baseline CT findings.
Time frame: 6 years
Plan to share: Yes — Upon PI approval, de-identified, coded data may be shared with other investigators conducting IRB-approved projects to establish a longitudinal data repository to support future IRB-approved research on early detection, prevention, and management of pulmonary and cardiothoracic conditions. Genetic testing, biospecimen collection, quantitative imaging re-analysis, or other analyses are not currently planned. Recipients will be required to adhere to institutional data protection standards.
Supporting information: Study protocol, Statistical analysis plan
No publications or documents are linked to this record.
Started Sep 2025 (actual). Primary completion is estimated for Sep 2030, 60 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.