A Study of the Use of Computer Software for the Detection of Lung Diseases Over Time
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 15-003799
Sponsor Protocol Number: 15-003799
About this study
The purpose of this study is to characterize lungs in normal healthy people without evidence of a pre-existing lung disease using computer software called CALIPER (Computer Aided Lung Informatics for Pathology Evaluation and Rating) and to follow the normal changes associated with aging over time.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- Age ≥ 18 years
- Lifelong never-smoker (never smoked, or <100 cigarettes lifetime used and not currently using [within 30 days])
- No prior history of chronic lung disease
- Signed informed consent
Exclusion Criteria
- BMI < 18 or > 35
- Pneumonia or bronchitis within past 6 weeks
- History of metallic chest hardware (sternotomy wires, metallic rib fixation, spineinstrumentation, shoulder replacements, pacemaker/defibrillator) or lung surgery
- Pregnancy (based on urine pregnancy test)
- History of chronic lung disease or treatment with inhaler medications, chronic heart disease (e.g. heart failure, valvular disease), connective tissue disease (e.g. lupus, rheumatoid arthritis, scleroderma, Sjögren’s, dermatomyositis/polymyositis), vasculitis, systemic malignancy
- History of amiodarone, chemotherapy drugs, anti-rheumatic drugs, or prolonged use of nitrofurantoin for >6 mos
- Significant home/occupational inhaled dust/smoke exposure (>12 mos asbestos, silica, beryllium; >5 years secondhand smoke)
- Current or prior routine smoking of non-tobacco products >1x/month
- Symptoms of chronic lung disease on ATS-DLD-78 Questionnaire
- Abnormal FEV1 or FVC on baseline spirometry, or ‘unacceptable’ spirometry
- Further, for patients that do obtain a CT scan, that data will be excluded from analysis if
- Lungs are deemed clinically abnormal by expert radiologist opinion
- TLCct <80% predicted physiologic TLC by standard reference calculations
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Brian Bartholmai, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available