Randomized Study of Positron Emission Tomography - Computed Tomography (PET/CT) in Pre-Operative Staging of Lung Cancer
Randomized Study of PET/CT in Pre-Operative Staging of Lung Cancer
研究概览
详细说明
Patients with possible operable NSCLC after staging with CT are randomised to PET-CT with FDG or not, prior to mediastinoscopy. All patients are referred to mediastinoscopy unless a positive FDG uptake results in a positive biopsy suggesting stage IV disease.
Biopsies are performed according to the following criteria:
- Lymph nodes are numbered according the Mountain classification, and abnormal lesions must be confirmed histologically, by mediastinoscopy or thoracotomy.
- PET-positive lesions in the liver must be biopsied unless ultrasound or MRI unequivocally indicate the lesions are benign cysts or haemangioma.
- PET-negative adrenal lesions are accepted without biopsy if CT scan indicate the lesion is a benign adenoma.
- PET-positive bone lesions must be evaluated by plain x-ray, CT, MRI, or bone scintigraphy. In case of equivocal findings a biopsy must be performed.
- PET-positive brain lesions must be confirmed by CT or MRI.
Number of patients:
Patients with clinically operable NSCLC after CT-staging are included. All patients must have mediastinoscopy performed.
All patients referred to mediastinoscopy can be randomised after informed consent. A total of 430 consecutive, non-selected patients are planned. It is anticipated that approximately 60% of the referred patients with clinical stage I-IIIa NSCLC will undergo thoracotomy, and a risk of type I and II error of 5% and 10%, respectively, is accepted. Thus a total of 215 patients are randomised in each arm in order to observe an absolute difference of 15% in the number of thoracotomies. This number seems to be sufficient to evaluate differences in the secondary endpoints.
After inclusion of a total of 220 patients, corresponding to 110 PET-scans, an interim analyses are performed. In case of a highly significant difference in the number of thoracotomies (p < 0,001) the study will be closed.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Copenhagen、丹麦、2100
- PET & Cyclotron Unit, Rigshospitalet,
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Clinically operable NSCLC after CT
- Fit for thoracotomy and lobectomy or pneumectomy after lung function tests
- CT-scan of thorax, including liver and adrenals with no signs of distant metastases.
- No medical condition contraindication surgery.
- Age 18-80
- No claustrophobia.
- Negative pregnancy test.
- No diabetes mellitus.
- Signed informed consent.
Exclusion Criteria:
- Radiologically M1 disease.
- Pregnancy
- Known claustrophobia.
- Estimated FEV1 < 30% of expected after surgery.
- Diabetes mellitus.
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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Conventional staging
Staging with CT, mediastinoscopy and bronchoscopy
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Conventional staging and PET/CT
Staging with CT, mediastinoscopy and bronchoscopy, and PET/CT performed prior to mediastinoscopy
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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Number of futile thoracotomies
大体时间:Within 1 year
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Within 1 year
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次要结果测量
结果测量 |
大体时间 |
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Number of thoracotomies and survival
大体时间:Within 1 year
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Within 1 year
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合作者和调查者
出版物和有用的链接
一般刊物
- Fischer BM, Mortensen J, Hansen H, Vilmann P, Larsen SS, Loft A, Bertelsen AK, Ravn J, Clementsen P, Hoegholm A, Larsen KR, Dirksen A, Skov BG, Krasnik M, Hojgaard L, Lassen U. Multimodality approach to mediastinal staging in non-small cell lung cancer. Faults and benefits of PET-CT: a randomised trial. Thorax. 2011 Apr;66(4):294-300. doi: 10.1136/thx.2010.154476. Epub 2010 Dec 17.
- Fischer B, Lassen U, Mortensen J, Larsen S, Loft A, Bertelsen A, Ravn J, Clementsen P, Hogholm A, Larsen K, Rasmussen T, Keiding S, Dirksen A, Gerke O, Skov B, Steffensen I, Hansen H, Vilmann P, Jacobsen G, Backer V, Maltbaek N, Pedersen J, Madsen H, Nielsen H, Hojgaard L. Preoperative staging of lung cancer with combined PET-CT. N Engl J Med. 2009 Jul 2;361(1):32-9. doi: 10.1056/NEJMoa0900043. Erratum In: N Engl J Med. 2011 Mar 10;364(10):982.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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