Clinical trial · Observational
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
NCT00867412CI-TRIAL-00002149completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Patients with possible operable non-small cell lung cancer are randomised to conventional staging, or conventional staging and PET/CT. According to, patients with operable tumor will be referred to surgery, and the number of thoracotomies and futile thoracotomies wil be compared with the two groups in order to asses the possible benefit of PET/CT.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Thoracotomy | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Conventional staging
- description
- Staging with CT, mediastinoscopy and bronchoscopy
- label
- Conventional staging and PET/CT
- description
- Staging with CT, mediastinoscopy and bronchoscopy, and PET/CT performed prior to mediastinoscopy
Primary outcomes (1)
- measure
- Number of futile thoracotomies
- timeFrame
- Within 1 year
Secondary outcomes (1)
- measure
- Number of thoracotomies and survival
- timeFrame
- Within 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Clinically operable NSCLC after CT 2. Fit for thoracotomy and lobectomy or pneumectomy after lung function tests 3. CT-scan of thorax, including liver and adrenals with no signs of distant metastases. 4. No medical condition contraindication surgery. 5. Age 18-80 6. No claustrophobia. 7. Negative pregnancy test. 8. No diabetes mellitus. 9. Signed informed consent. Exclusion Criteria: 1. Radiologically M1 disease. 2. Pregnancy 3. Known claustrophobia. 4. Estimated FEV1 \< 30% of expected after surgery. 5. Diabetes mellitus.
References
Publications (2)
- DERIVEDFischer 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. PMID 21169287
- DERIVEDFischer 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. PMID 19571281