- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00136890
PET Imaging in Potentially Surgically Resectable Non-small Cell Lung Cancers (ELPET)
The Impact of Positron Emission Tomography (PET) Imaging in Staging Potentially Surgically Resectable Non-small Cell Lung Cancers: A Prospective Multicentre Randomized Clinical Trial
Lung cancer remains the leading cause of cancer deaths in men and women. Although overall survival remains poor, early stage non-small cell lung cancer (NSCLC) is potentially curable. Improved staging has led to stage-specific therapies such that patients with early stage NSCLC are potential candidates for surgical resection, and those with more advanced disease are spared the morbidity and risk of mortality from thoracotomy and pulmonary resection. Despite contemporary staging techniques, 25-50% of patients who appear to have limited disease amenable to surgical resection go on to die from metastatic lung cancer. If occult micro-metastatic disease that becomes evident later could be detected reliably during the pre-operative assessment, patients harboring such disease could be spared a non-curative thoracotomy. PET imaging has the potential to detect mediastinal and extrathoracic metastatic disease not detected by conventional imaging modalities.
This prospective, multicenter trial will enroll patients with biopsy-proven clinical stage I-IIIA NSCLC who are considered to be candidates for surgical resection with curative intent. Preoperatively, patients will be randomized to conventional staging for metastatic disease (CT liver/adrenals, total body bone scan, and CT with contrast or MRI with gadolinium of the brain) versus whole body PET or PET-CT and brain CT or MRI with contrast/gadolinium.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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-
Ontario
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Hamilton, Ontario, Canadá, L8N 4A6
- St. Joseph's Healthcare Hamilton
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London, Ontario, Canadá, N6A 4G5
- London Health Sciences Centre
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Mississauga, Ontario, Canadá, L5M 2N1
- Credit Valley
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Ottawa, Ontario, Canadá, K1H 8L6
- The Ottawa Hospital - General Campus
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Scarborough, Ontario, Canadá, M1P 2T7
- Scarborough Hospital
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Toronto, Ontario, Canadá, M5G 2C4
- Toronto General Hospital
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Toronto, Ontario, Canadá, M4N 3M5
- Sunnybrook/TEGH
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Toronto, Ontario, Canadá, M6R 1B5
- St. Joseph's Health Care
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Histological or cytological proof of NSCLC
- Stage I, II, or IIIA NSCLC based upon clinical staging
- The primary lesion appears technically appropriate for surgical resection, based on information from the chest x-ray (CXR) and CT thorax.
- Age over 18 years
Exclusion Criteria:
- Poor pulmonary function precluding radical surgery (inadequate pulmonary reserve for radical surgery) with predicted post-resection forced expiratory volume in 1 second (FEV1) < 0.8 liter or < 40% predicted, and diffusing capacity of the lung for carbon monoxide (DLCO) < 40% predicted
- Poor performance status (Eastern Cooperative Oncology Group [ECOG] 3-4)
- Significant concurrent medical problems (e.g. uncontrolled diabetes, active cardiac problems, significant chronic obstructive pulmonary disease) making the patient unfit for surgery
- Pregnant or lactating females
- Unable to lie supine for imaging with PET
- Patients with previously treated cancer other than non-melanotic skin cancer or carcinoma in situ of the cervix, unless disease-free for 5 years or greater
- Patients who, at the time of the initial evaluation, have already undergone a whole body PET/PET-CT, CT brain, MRI brain, total body bone scan or mediastinoscopy within 8 weeks prior to randomization will be excluded. However, patients who have had a CT scan of the thorax with abdomen are not excluded.
- Failure to provide informed consent
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Sin intervención: 1
Conventional Staging
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|
Experimental: 2
PET Imaging
|
Patients randomized to PET staging will undergo FDG-PET or PET-CT as well as some form of cranial imaging (CT or MRI)
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Patients correctly upstaged by PET versus conventional staging
Periodo de tiempo: November 2007
|
November 2007
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Patients erroneously understaged by PET versus conventional staging
Periodo de tiempo: November 2008
|
November 2008
|
Overall survival
Periodo de tiempo: August 2012
|
August 2012
|
Prognostic ability of PET standard uptake value
Periodo de tiempo: August 2011
|
August 2011
|
Sensitivity and specificity of PET in the mediastinum
Periodo de tiempo: November 2008
|
November 2008
|
Cost-effectiveness of using PET versus conventional staging
Periodo de tiempo: August 2012
|
August 2012
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Mark N Levine, MD, Ontario Clinical Oncology Group (OCOG)
- Silla de estudio: Donna E Maziak, MD, The Ottawa Hospital
- Silla de estudio: Gail E Darling, MD, Toronto General Hospital
- Investigador principal: William Evans, MD, Juravinski Cancer Centre
Publicaciones y enlaces útiles
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 (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CTA-Control-088145
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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