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

COPD Clinical Trial

— FD-COPD  

Official title:

Non-contrast-enhanced Perfusion Imaging of the Lung Using Fourier Decomposition Magnetic Resonance Imaging (FD MRI): Assessment of Feasibility in Patients With COPD in Correlation With Perfusion Scintigraphy, SPECT/CT and DCE MRI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02367209
• Other study ID #: FD-COPD-2015-002
• Status: Completed
• Phase: N/A
• First received: February 12, 2015
• Last updated: July 10, 2017
• Start date: February 2015
• Est. completion date: June 2017

Study information

• Verified date: July 2017
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: June 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• COPD
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Switzerland	University of Basel Hospital, Clinic of Radiology and Nuclear Medicine	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative perfusion	Relative perfusion of individual pulmonary lobes expressed in % of total (bilateral) lung perfusion	14 month
Secondary	Image quality	Subjective classification by two independent readers	14 month
Secondary	Perfusion defects	Inter-reader agreement concerning the presence of circumscribed perfusion defects	14 month