Assessment of Lung Perfusion in Patients With Chronic Obstructive Pulmonary Disease Using FD MRI

Completed

• Conditions: COPD

• Registration Number: NCT02367209
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

In the recent years a novel method for functional lung imaging called Fourier decomposition MRI (FD MRI) has been introduced that allows for simultaneous assessment of regional lung perfusion and ventilation-related information without exposure to ionizing radiation or administration of intravenous or inhalational contrast agent. In this project, the investigators plan to investigate whether Fourier decomposition (FD) MRI is able to provide similar clinical information on regional lung perfusion as the standard methods SPECT/CT and DCE MRI in patients with COPD.

Detailed Description

In the recent years a novel method for functional lung imaging called Fourier decomposition MRI (FD MRI) has been introduced that allows for simultaneous assessment of regional lung perfusion and ventilation-related information without exposure to ionizing radiation or administration of intravenous or inhalational contrast agent.

In this project, the investigators plan to investigate whether Fourier decomposition (FD) MRI is able to provide similar clinical information on regional lung perfusion as the standard methods SPECT/CT and DCE MRI in patients with COPD. As MRI in patients with COPD is particularly challenging due to the rarefication of lung parenchyma, the FD MRI technique will be combined with an ultra-fast Steady-State Free Precession (ufSSFP) acquisition method for improved signal efficiency. The investigators ultimate goal is to provide a mean to predict and monitor the outcome of different therapies, such as medication, valves and surgery in COPD patients without requiring ionizing radiation or administration of contrast agents.

In the framework of this study, 30 patients with COPD will be enrolled prospectively. The study participants will be recruited by the clinic for thoracic surgery at the University Hospital Basel among all patients undergoing lung perfusion scintigraphy with SPECT/CT for surgery planning. Each participant will undergo one MRI examination of 30 min containing non-contrast-enhanced (FD MRI) and contrast-enhanced (DCE MRI) imaging studies of regional lung perfusion.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-12
• Study First Submitted QC: 2015-02-19
• Study First Posted: 2015-02-20
• Primary Completion: 2016-12
• Study Completion: 2017-06
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-10
• Last Update Posted: 2017-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Informed Consent as documented by signature

Exclusion Criteria

• Known hypersensitivity or allergy to Gd-based MRI contrast agents.
• Patients with cardiac pacemakers, intra cranial clips, metallic foreign bodies^or other not MRcompatible implants (e.g. pumps etc.).
• Renal failure or severely impaired kidney function (eGFR < 30 ml/min /1,73 m2)
• Known or suspected non-compliance, claustrophobia.
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
• Epilepsy.
• Age <18 years.
• Previous enrolment into the current study.
• Enrolment of the investigator, his/her family members, employees and other dependent persons.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relative perfusion	14 month	Relative perfusion of individual pulmonary lobes expressed in % of total (bilateral) lung perfusion

Secondary Outcome Measures

Name	Time	Method
Image quality	14 month	Subjective classification by two independent readers
Perfusion defects	14 month	Inter-reader agreement concerning the presence of circumscribed perfusion defects

Trial Locations

Locations (1)

University of Basel Hospital, Clinic of Radiology and Nuclear Medicine; 🇨🇭 Basel, Switzerland