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.
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
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Ontario
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Hamilton、Ontario、カナダ、L8N 4A6
- St. Joseph's Healthcare Hamilton
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London、Ontario、カナダ、N6A 4G5
- London Health Sciences Centre
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Mississauga、Ontario、カナダ、L5M 2N1
- Credit Valley
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Ottawa、Ontario、カナダ、K1H 8L6
- The Ottawa Hospital - General Campus
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Scarborough、Ontario、カナダ、M1P 2T7
- Scarborough Hospital
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Toronto、Ontario、カナダ、M5G 2C4
- Toronto General Hospital
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Toronto、Ontario、カナダ、M4N 3M5
- Sunnybrook/TEGH
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Toronto、Ontario、カナダ、M6R 1B5
- St. Joseph's Health Care
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:診断
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
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介入なし:1
Conventional Staging
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実験的:2
PET Imaging
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Patients randomized to PET staging will undergo FDG-PET or PET-CT as well as some form of cranial imaging (CT or MRI)
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
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Patients correctly upstaged by PET versus conventional staging
時間枠:November 2007
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November 2007
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二次結果の測定
結果測定 |
時間枠 |
---|---|
Patients erroneously understaged by PET versus conventional staging
時間枠:November 2008
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November 2008
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Overall survival
時間枠:August 2012
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August 2012
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Prognostic ability of PET standard uptake value
時間枠:August 2011
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August 2011
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Sensitivity and specificity of PET in the mediastinum
時間枠:November 2008
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November 2008
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Cost-effectiveness of using PET versus conventional staging
時間枠:August 2012
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August 2012
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協力者と研究者
捜査官
- 主任研究者:Mark N Levine, MD、Ontario Clinical Oncology Group (OCOG)
- スタディチェア:Donna E Maziak, MD、The Ottawa Hospital
- スタディチェア:Gail E Darling, MD、Toronto General Hospital
- 主任研究者:William Evans, MD、Juravinski Cancer Centre
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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