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Multimodality approach to mediastinal staging in non-small cell lung cancer. Faults and benefits of PET-CT: a randomised trial
  1. Barbara M Fischer1,2,
  2. Jann Mortensen1,
  3. Hanne Hansen3,
  4. Peter Vilmann4,
  5. Søren S Larsen5,
  6. Annika Loft1,
  7. Anne K Bertelsen1,
  8. Jesper Ravn6,
  9. Paul Clementsen7,
  10. Asbjørn Høegholm8,
  11. Klaus R Larsen9,
  12. Asger Dirksen7,
  13. Birgit G Skov10,
  14. Mark Krasnik11,
  15. Liselotte Højgaard1,
  16. Ulrik Lassen12
  1. 1Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark
  2. 2Department of Clinical Physiology and Nuclear Medicine, Hvidovre Hospital, Hvidovre, Denmark
  3. 3Department of Radiology, Bispebjerg Hospital, Copenhagen, Denmark
  4. 4Department of Surgery, Herlev Hospital, Endoscopic Unit at Gentofte Hospital, Hellerup, Denmark
  5. 5Department of Surgery, Hvidovre Hospital, Hvidovre, Denmark
  6. 6Department of Thoracic Surgery, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark
  7. 7Department of Pulmonology, Gentofte Hospital, Hellerup, Denmark
  8. 8Department of Pulmonology, Naestved Hospital, Næstved, Denmark
  9. 9Department of Pulmonology, Bispebjerg Hospital, Copenhagen, Denmark
  10. 10Department of Pathology, Bispebjerg Hospital, Copenhagen, Denmark
  11. 11Department of Development and Quality, Copenhagen University Hospital, Copenhagen, Denmark
  12. 12Department of Oncology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark
  1. Correspondence to Barbara M Fischer, Department of Clinical Physiology and Nuclear Medicine, Hvidovre Hospital, section 239, Kettegaard Allé 30, 2650 Hvidovre, Denmark; bjerregaard.fischer{at}


Background Correct mediastinal staging is a cornerstone in the treatment of patients with non-small cell lung cancer. A large range of methods is available for this purpose, making the process of adequate staging complex. The objective of this study was to describe faults and benefits of positron emission tomography (PET)-CT in multimodality mediastinal staging.

Methods A randomised clinical trial was conducted including patients with a verified diagnosis of non-small cell lung cancer, who were considered operable. Patients were assigned to staging with PET-CT (PET-CT group) followed by invasive staging (mediastinoscopy and/or endoscopic ultrasound with fine needle aspiration (EUS-FNA)) or invasive staging without prior PET-CT (conventional work up (CWU) group). Mediastinal involvement (dichotomising N stage into N0–1 versus N2–3) was described according to CT, PET-CT, mediastinoscopy, EUS-FNA and consensus (based on all available information), and compared with the final N stage as verified by thoracotomy or a conclusive invasive diagnostic procedure.

Results A total of 189 patients were recruited, 98 in the PET-CT group and 91 in the CWU group. In an intention-to-treat analysis the overall accuracy of the consensus N stage was not significantly higher in the PET-CT group than in the CWU group (90% (95% confidence interval 82% to 95%) vs 85% (95% CI 77% to 91%)). Excluding the patients in whom PET-CT was not performed (n=14) the difference was significant (95% (95% CI 88% to 98%) vs 85% (95% CI 77% to 91%), p=0.034). This was mainly based on a higher sensitivity of the staging approach including PET-CT.

Conclusion An approach to lung cancer staging with PET-CT improves discrimination between N0–1 and N2–3. In those without enlarged lymph nodes and a PET-negative mediastinum the patient may proceed directly to surgery. However, enlarged lymph nodes on CT needs confirmation independent of PET findings and a positive finding on PET-CT needs confirmation before a decision on surgery is made.

Clinical trial number NCT00867412.

  • Positron emission tomography
  • neoplasm staging
  • carcinoma, non-small-cell lung
  • endosonography
  • randomised controlled trial
  • imaging/CT MRI etc
  • lung cancer
  • non-small cell lung cancer
  • thoracic surgery

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  • See Editorial, p 275

  • Funding Danish Cancer Society and the Danish Center for Health Technology Assessment.

  • Competing interests None.

  • Ethics approval This study was conducted with the approval of the Ethics Committee and Institutional Review Board of Copenhagen Hospitals.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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