Randomized Study of Positron Emission Tomography - Computed Tomography (PET/CT) in Pre-Operative Staging of Lung Cancer

NCT00867412 | Completed

• 1 other identifier: PERALUST
• Study Type: observational
• Target: 189
• Locations: 1 country
• Sites: 1

Brief Summary

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

Non-Small Cell Lung Cancer; Thoracotomy

Keywords

NSCLC; PET/CT; Surgery; FDG; staging

Outcome Measures

Primary Outcomes (1)

• Number of futile thoracotomies

  Within 1 year

Secondary Outcomes (1)

• Number of thoracotomies and survival

  Within 1 year

Study Arms (2)

Conventional staging

Staging with CT, mediastinoscopy and bronchoscopy

Conventional staging and PET/CT

Staging with CT, mediastinoscopy and bronchoscopy, and PET/CT performed prior to mediastinoscopy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with non-small cell lung cancer

You may qualify if:

• 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.

You may not qualify if:

• Radiologically M1 disease.
• Pregnancy
• Known claustrophobia.
• Estimated FEV1 \< 30% of expected after surgery.
• Diabetes mellitus.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Danish Cancer Society: collaborator
• Danish Centre for Health Technology Assessment: collaborator

Study Sites (1)

PET & Cyclotron Unit, Rigshospitalet,

Copenhagen, 2100, Denmark

Location

Related Publications (2)

• 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.

  PMID: 21169287 DERIVED

• 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.

  PMID: 19571281 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 20, 2009
• First Posted: March 23, 2009
• Study Start: January 1, 2002
• Primary Completion: February 1, 2007
• Study Completion: February 1, 2008
• Last Updated: March 23, 2009

Record last verified: 2009-03

Locations

DK (1)