- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00867412
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
Study Overview
Status
Conditions
Detailed Description
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Copenhagen, Denmark, 2100
- PET & Cyclotron Unit, Rigshospitalet,
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Number of futile thoracotomies
Time Frame: Within 1 year
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Within 1 year
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Number of thoracotomies and survival
Time Frame: Within 1 year
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Within 1 year
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PERALUST
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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