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Randomized Study of PET/CT in Pre-Operative Staging of Lung Cancer

18 Years
80 Years
Not Enrolling
Non-Small Cell Lung Cancer, Thoracotomy

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Trial Information

Randomized Study of PET/CT in Pre-Operative Staging of Lung Cancer

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.

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.

Type of Study:


Study Design:

Time Perspective: Prospective

Outcome Measure:

Number of futile thoracotomies

Outcome Time Frame:

Within 1 year

Safety Issue:



Denmark: The Regional Committee on Biomedical Research Ethics

Study ID:




Start Date:

January 2002

Completion Date:

February 2008

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Thoracotomy
  • PET/CT
  • Surgery
  • FDG
  • staging
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms