- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02367209
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
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Basel, Suiza, 4058
- University of Basel Hospital, Clinic of Radiology and Nuclear Medicine
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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):
- Preoperative assessment of regional lung perfusion before video-assisted lung volume resection (VATS-LVRS) in patients with COPD.
- 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%).
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Control de caso
- Perspectivas temporales: Futuro
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Relative perfusion
Periodo de tiempo: 14 month
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Relative perfusion of individual pulmonary lobes expressed in % of total (bilateral) lung perfusion
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14 month
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Image quality
Periodo de tiempo: 14 month
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Subjective classification by two independent readers
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14 month
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Perfusion defects
Periodo de tiempo: 14 month
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Inter-reader agreement concerning the presence of circumscribed perfusion defects
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14 month
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jens Bremerich, Prof., Klinik für Radiologie und Nuklearmedizin, Universitätsspital Basel
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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