COPDFD-COPDNCT02367209
Assessment of Lung Perfusion in Patients With Chronic Obstructive Pulmonary Disease Using FD MRI
An observational study of COPD, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COPD
- How many people
- 14 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2015to Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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%).
Who may be able to join
- Informed Consent as documented by signature
Who cannot join
- 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.
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- Age <18 years.
- Previous enrolment into the current study.
- Enrolment of the investigator, his/her family members, employees and other dependent persons.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University of Basel Hospital, Clinic of Radiology and Nuclear Medicine
Basel, 4058
About this study
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
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.
Read the 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.
- Conditions
- COPD
- Keywords
- FD MRI, COPD, SPECT/CT, DCE MRI
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative perfusion
Relative perfusion of individual pulmonary lobes expressed in % of total (bilateral) lung perfusion
Measured: 14 month
Secondary outcomes (2)
Image quality
Subjective classification by two independent readers
Measured: 14 month
Perfusion defects
Inter-reader agreement concerning the presence of circumscribed perfusion defects
Measured: 14 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionDec 2016
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jens Bremerich, Prof., Principal investigator, Klinik für Radiologie und Nuklearmedizin, Universitätsspital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02367209
- Sponsor's protocol ID
- FD-COPD-2015-002
- Acronym
- FD-COPD
- Status last verified
- Jul 2017
- First submitted
- 12 Feb 2015
- Last updated
- 13 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02367209
- Acronym / sponsor ID
- FD-COPD / FD-COPD-2015-002
- Conditions
- COPD
- Keywords
- FD MRI, COPD, SPECT/CT, DCE MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 20 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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%).
Key inclusion criteria (1 listed)
- Informed Consent as documented by signature
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Relative perfusion
Time frame: 14 month
Relative perfusion of individual pulmonary lobes expressed in % of total (bilateral) lung perfusion
2 secondary outcomes
Image quality
Time frame: 14 month
Perfusion defects
Time frame: 14 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Bremerich, Prof. principal investigator
Klinik für Radiologie und Nuklearmedizin, Universitätsspital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative perfusion (time frame: 14 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2017.