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

NCT02367209 | Completed

• 1 other identifier: FD-COPD-2015-002
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Keywords

FD MRI; COPD; SPECT/CT; DCE MRI

Outcome Measures

Primary Outcomes (1)

• Relative perfusion

  Relative perfusion of individual pulmonary lobes expressed in % of total (bilateral) lung perfusion

  14 month

Secondary Outcomes (2)

• Image quality

  14 month

• Perfusion defects

  14 month

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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%).

You may qualify if:

• Informed Consent as documented by signature

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University of Basel Hospital, Clinic of Radiology and Nuclear Medicine

Basel, 4058, Switzerland

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jens Bremerich, Prof.

  Klinik für Radiologie und Nuklearmedizin, Universitätsspital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2015
• First Posted: February 20, 2015
• Study Start: February 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: June 1, 2017
• Last Updated: July 13, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)