MRI study to investigate lung diseases (COPD and Asthma)

Open monocentric clinical pilot study in COPD und Asthma patients to investigate static as well as dynamic ventilation, intrapulmonary ADC and pO2 using helium-3-MRI after inhalation of hyperpolarised helium-3 gas; a comparison with pulmonary function tests und H-MRI (long-term observation) - COALA-HE

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-021782-70-DE

Enrollment

Registered

2010-11-25

Start date

2011-06-22

Completion date

Unknown

Last updated

2015-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The study is a diagnostic pilot study on COPD and Asthma patients MedDRA version: 14.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.0 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Product Name: hyperpolarized Helium-3 Pharmaceutical Form: Inhalation gas CAS Number: 14762-55-1 Concentration unit: ml millilitre(s) Concentration type: up to Concentration number: 6000-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Group 1: COPD: adults > 40years and 18 years and =65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: pregnacy instable clinical status MRI contraindications. metallic implants, claustrophobia myocardial infarctus or cerebrovascular insult during the last 6 weeks other acute lung diease within the last 6 weeks prior to the first visit exacerbations during the last 6 months renal dysfunction (gfr<60mL/min)

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of the trial is to investigate the He-MRI parameters in comparison with proton-MRI und pulmonary function tests in two patient groups and the change of these parameters after 1 year (including the effect of a bronchodilator);Secondary Objective: The secondary objective is to investigate the safety of helium-3 and the correlation between the different methods.;Primary end point(s): disease specific findings: He-MRI prior to and after bronchodilation;Timepoint(s) of evaluation of this end point: After completion of the first examination and after completion of the second examination of all patients	—

Measure

Time frame

Main Objective: The main objective of the trial is to investigate the He-MRI parameters in comparison with proton-MRI und pulmonary function tests in two patient groups and the change of these parameters after 1 year (including the effect of a bronchodilator);Secondary Objective: The secondary objective is to investigate the safety of helium-3 and the correlation between the different methods.;Primary end point(s): disease specific findings: He-MRI prior to and after bronchodilation;Timepoint(s) of evaluation of this end point: After completion of the first examination and after completion of the second examination of all patients

—

Secondary

Measure	Time frame
Secondary end point(s): Correlation of MRI parameters and lung function parameters;Timepoint(s) of evaluation of this end point: After completion of the first examination and after completion of the second examination of all patients	—

Countries

Germany

Contacts

Public ContactChristoph Düber

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

dueber@radiologie.klinik.uni-mainz.de496131177371

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026