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

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.

Study Overview

• Status: Completed
• Conditions: Non-Small Cell Lung Cancer; Thoracotomy

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:

1. Lymph nodes are numbered according the Mountain classification, and abnormal lesions must be confirmed histologically, by mediastinoscopy or thoracotomy.
2. PET-positive lesions in the liver must be biopsied unless ultrasound or MRI unequivocally indicate the lesions are benign cysts or haemangioma.
3. PET-negative adrenal lesions are accepted without biopsy if CT scan indicate the lesion is a benign adenoma.
4. 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.
5. 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
• Enrollment (Actual): 189

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • PET & Cyclotron Unit, Rigshospitalet,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with non-small cell lung cancer

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of futile thoracotomies	Within 1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of thoracotomies and survival	Within 1 year

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: Danish Cancer Society; Danish Centre for Health Technology Assessment

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: January 1, 2002
• Primary Completion (Actual): February 1, 2007
• Study Completion (Actual): February 1, 2008

Study Registration Dates

• First Submitted: March 20, 2009
• First Submitted That Met QC Criteria: March 20, 2009
• First Posted (Estimate): March 23, 2009

Study Record Updates

• Last Update Posted (Estimate): March 23, 2009
• Last Update Submitted That Met QC Criteria: March 20, 2009
• Last Verified: March 1, 2009

More Information

Terms related to this study

• Keywords: PET/CT; NSCLC; Surgery; staging; FDG
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: PERALUST