Using lung cancer screening CT scans to find COPD (MAP2)

University of Michigan COPD Identification Through Lung Cancer Screening Cohort Study - MAP2

This project will use lung cancer screening CT scans and spirometry in current and former smokers aged 50–80 with at least 20 pack-years to see if CT findings can identify people who have COPD.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 50 Years to 80 Years
• Sex: All
• Sponsor: University of Michigan (other)
• Drugs / interventions: radiation, prednisone
• Locations: 1 site (Ann Arbor, Michigan)
• Trial ID: NCT07482475 on ClinicalTrials.gov

What this trial studies

This observational cohort enrolls current and former smokers eligible for USPSTF lung cancer screening (age 50–80, ≥20 pack-years) who had a clinical screening CT at the University of Michigan within the past year. Investigators will analyze existing low-dose CT images for emphysema-like changes (for example, LAA>1%) and will verify COPD status using available or study-performed spirometry (FEV1/FVC ≤0.70). Eligible participants include those with a prior COPD diagnosis, prior obstructive spirometry, or CT evidence of emphysema, and the study links imaging and pulmonary function data to characterize COPD detection by CT. The cohort may also be contacted for future ancillary studies, including possible interventional trials.

Who should consider this trial

Good fit: Ideal candidates are current or former smokers aged 50–80 with at least 20 pack-years who had a University of Michigan lung cancer screening CT within the past year and can perform spirometry and provide consent.

Not a fit: Patients without the required smoking history or age/pack-year criteria, those with primary non-COPD respiratory diseases, or those unable to tolerate spirometry are unlikely to benefit.

Why it matters

Potential benefit: If successful, this approach could find undiagnosed COPD during routine lung cancer screening so patients get earlier monitoring and treatment.

How similar studies have performed: Previous research shows CT-based emphysema measures often correlate with spirometry and can identify undiagnosed COPD, but routine implementation within lung cancer screening programs is still emerging.

Eligibility criteria

Inclusion Criteria:

* Eligible for lung cancer screening by USPSTF 2021 criteria including age 50-80 years and currently or formerly smoking with at last 20 pack-years of smoking history at the time of consent.
* Willingness to participate in an observational clinical trial and to be contacted about future ancillary studies that could include interventional clinical trials.
* Ability to tolerate study procedures.
* Ability to provide informed consent.
* Clinical Lung Cancer Screening CT performed at the University of Michigan within the last year
* Meets one of the three following criteria:

  1. Prior Diagnosis of COPD in the EMR
  2. Prior pulmonary function meeting criteria for COPD (FEV1/FVC ≤ 0.70) or
  3. LAA\>1% on lung cancer screening CT scan

Exclusion Criteria:

* The presence of a respiratory condition other than COPD or asthma, or of a comorbid condition that in the judgment of the investigator may be the principal cause of respiratory symptoms (e.g. dyspnea or decreased exercise tolerance).
* Severe asthma, which is defined as any of the following:

Current (i.e. at the time of the visit) GINA Step 4 or higher therapy (medium dose ICS/LABA or high dose ICS or add-on LAMA; Medium dose = \>250 fluticasone propionate =100 fluticasone furoate, \>200 beclomethasone, \>400 budesonide, \>220 mometasone). The investigators will accept low-dose ICS/LABA or medium dose ICS.

or 3 or more unscheduled healthcare visits (provider/urgent care/ER) for asthma in the past 12 months or One asthma hospitalization in the past 12 months

* Concurrent participation in a therapeutic trial where treatment is blinded.
* Active pregnancy. Documentation of birth control will be required for pre-menopausal women.
* Cognitive dysfunction that prevents the participant from completing study procedures.
* BMI \> 35 kg/m2 at baseline, due to the effects of body weight on CT scan quality.
* Current illicit substance abuse, including cannabis smoking.
* Any illness expected to cause mortality in the next 3 years.
* Any implanted metallic devices or prosthesis above the waist that could degrade thoracic CT scan quality.
* History of thoracic radiation or thoracic surgery with resection of lung tissue.

Additional temporal exclusion criteria are as follows:

* Participants who present with an acute exacerbation of COPD, either solely participant-identified or that has been clinically treated, in the last 30 days can be rescreened for the study once the 30-day window from end of drug therapy has passed.
* Participants who present with current use of acute antibiotics or steroids can be rescreened for the study ≥30 days after discontinuing acute antibiotics/steroids. This restriction does not apply to participants who are on chronic prednisone therapy of \<10 mg per day or \<20 mg every other day or participants who are currently on chronic, prophylactic, or suppressive antibiotic therapy.

Where this trial is running

Ann Arbor, Michigan

• University of Michigan — Ann Arbor, Michigan, United States (RECRUITING)

Conditions: COPD, Cancer Lung Screening, Smoking Cigarette