- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
-
-
Ontario
-
Hamilton, Ontario, Canada, L8N 4A6
- St. Joseph's Healthcare Hamilton
-
London, Ontario, Canada, N6A 4G5
- London Health Sciences Centre
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Mississauga, Ontario, Canada, L5M 2N1
- Credit Valley
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Ottawa, Ontario, Canada, K1H 8L6
- The Ottawa Hospital - General Campus
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Scarborough, Ontario, Canada, M1P 2T7
- Scarborough Hospital
-
Toronto, Ontario, Canada, M5G 2C4
- Toronto General Hospital
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Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook/TEGH
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Toronto, Ontario, Canada, M6R 1B5
- St. Joseph's Health Care
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Aucune intervention: 1
Conventional Staging
|
|
Expérimental: 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)
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Patients correctly upstaged by PET versus conventional staging
Délai: November 2007
|
November 2007
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
Patients erroneously understaged by PET versus conventional staging
Délai: November 2008
|
November 2008
|
Overall survival
Délai: August 2012
|
August 2012
|
Prognostic ability of PET standard uptake value
Délai: August 2011
|
August 2011
|
Sensitivity and specificity of PET in the mediastinum
Délai: November 2008
|
November 2008
|
Cost-effectiveness of using PET versus conventional staging
Délai: August 2012
|
August 2012
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Mark N Levine, MD, Ontario Clinical Oncology Group (OCOG)
- Chaise d'étude: Donna E Maziak, MD, The Ottawa Hospital
- Chaise d'étude: Gail E Darling, MD, Toronto General Hospital
- Chercheur principal: William Evans, MD, Juravinski Cancer Centre
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CTA-Control-088145
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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