Substudy 1: Healthy subjects
Conditions
Interventions
Group 1: Arm 1 (Cohort 1): Healthy subjects undergoing ASL MRI (2 scans) of the lungs on a 1.5T scanner.
Group 2: Arm 2 (Cohorts 2–4): Patients undergoing ASL MRI (1 scan) of the lungs.
For the patie
Cohort 3: CTPA, echocardiography
Cohort 4: MRI, spirometry).
Sponsors
Universitätsklinikum Tübingen, Radiologie, Abt. für Diagnostische & Interventionelle Radiologie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Cohort 1: • Healthy volunteers • Consent to be notified of incidental findings Cohort 2: • Clinical indication for pulmonary perfusion scintigraphy Cohort 3: • Clinical indication for follow-up after acute pulmonary embolism (APE) and detection of thrombi on CTPA • Hemodynamically stable patients • No intensive care required Cohort 4: • Patients diagnosed with cystic fibrosis • Children, adolescents, and adults (generally ages 5 and up) • Clinical indication for routine MRI without anesthesia
Exclusion criteria
Exclusion criteria: Cohorts 1–4 • Pregnant or breastfeeding women • General contraindications for an MRI scan • Need for anesthesia to perform an MRI • No written consent from the subject, patient, or legal guardian • Cohort 1 only: Smokers, acute or chronic lung disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quantitative measurement of pulmonary perfusion in ml/min/100 ml in a defined region of interest in healthy subjects (cohort 1). Exploratory assessment of diagnostic agreement between ASL perfusion MRI and pulmonary scintigraphy regarding the detection of regional pulmonary perfusion defects in patients with indication for pulmonary scintigraphy (cohort 2) Percentage of the lung with a perfusion defect following acute pulmonary embolism (cohort 3). Difference in the ASL perfusion defect score between patients with mild versus moderate/severe structural MRI findings in patients with cystic fibrosis (CF) (cohort 4). | — |
Secondary
| Measure | Time frame |
|---|---|
| Cohort 1: Comparison of ASL methods with regard to different labeling strategies, evaluation of optimal ASL-MRI parameter settings for measuring pulmonary perfusion, reproducibility. Cohort 2: Correlation between ASL perfusion MRI and pulmonary scintigraphy with regard to perfusion patterns. Cohort 3: Association between ASL MRI perfusion findings and echocardiographic parameters as well as cardiac biomarkers, comparison of perfusion defects, incidence of residual pulmonary perfusion defects three months after acute pulmonary embolism. Cohort 4: Feasibility of pulmonary ASL-MRI in a clinical setting with cystic fibrosis (CF), particularly in pediatric patients, correlations between structural lesions on MRI and regional perfusion deficits in CF patients. | — |
Countries
Germany
Contacts
Public ContactCecilia Liang
Universitätsklinikum Tübingen, Radiologie, Abt. für Diagnostische und Interventionelle Radiologie,
Outcome results
None listed