Assessment of Lung Perfusion in Patients With Chronic Obstructive Pulmonary Disease Using FD MRI (FD-COPD)

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

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.

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 14

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4058
    • University of Basel Hospital, Clinic of Radiology and Nuclear Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study participants will be recruited by the department of thoracic surgery at the University Hospital Basel among all patients who undergo Perfusion scintigraphy and SPECT/CT of the lung with 99mTc-MAA for one of the following clinical indications (of note: this selection of patients does per se exclude pregnant women):

1. Preoperative assessment of regional lung perfusion before video-assisted lung volume resection (VATS-LVRS) in patients with COPD.
2. Preoperative assessment of regional lung perfusion before segmentectomy, lobectomy or pneumonectomy procedures with curative intention in NSCLC patients with concomitant COPD and reduced pulmonary function parameters (FEV1 < 80%).

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative perfusion	Relative perfusion of individual pulmonary lobes expressed in % of total (bilateral) lung perfusion	14 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Image quality	Subjective classification by two independent readers	14 month
Perfusion defects	Inter-reader agreement concerning the presence of circumscribed perfusion defects	14 month

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Jens Bremerich, Prof., Klinik für Radiologie und Nuklearmedizin, Universitätsspital Basel

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: February 12, 2015
• First Submitted That Met QC Criteria: February 19, 2015
• First Posted (Estimate): February 20, 2015

Study Record Updates

• Last Update Posted (Actual): July 13, 2017
• Last Update Submitted That Met QC Criteria: July 10, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: COPD; FD MRI; SPECT/CT; DCE MRI
• Other Study ID Numbers: FD-COPD-2015-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No