Randomized Study of Positron Emission Tomography - Computed Tomography (PET/CT) in Pre-Operative Staging of Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00867412|
Recruitment Status : Completed
First Posted : March 23, 2009
Last Update Posted : March 23, 2009
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|Condition or disease|
|Non-Small Cell Lung Cancer Thoracotomy|
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.
|Study Type :||Observational|
|Actual Enrollment :||189 participants|
|Official Title:||Randomized Study of PET/CT in Pre-Operative Staging of Lung Cancer|
|Study Start Date :||January 2002|
|Actual Primary Completion Date :||February 2007|
|Actual Study Completion Date :||February 2008|
Staging with CT, mediastinoscopy and bronchoscopy
Conventional staging and PET/CT
Staging with CT, mediastinoscopy and bronchoscopy, and PET/CT performed prior to mediastinoscopy
- Number of futile thoracotomies [ Time Frame: Within 1 year ]
- Number of thoracotomies and survival [ Time Frame: Within 1 year ]
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|Ages Eligible for Study:||18 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Probability Sample|
- 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.
- Radiologically M1 disease.
- Known claustrophobia.
- Estimated FEV1 < 30% of expected after surgery.
- Diabetes mellitus.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00867412
|PET & Cyclotron Unit, Rigshospitalet,|
|Copenhagen, Denmark, 2100|
|Responsible Party:||Ulrik Lassen, MD., PH.D, Rigshospitalet|
|Other Study ID Numbers:||
|First Posted:||March 23, 2009 Key Record Dates|
|Last Update Posted:||March 23, 2009|
|Last Verified:||March 2009|
Respiratory Tract Neoplasms
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