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

This study has been completed.
Sponsor:
Collaborators:
Danish Cancer Society
Danish Centre for Health Technology Assessment
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00867412
First received: March 20, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

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.


Condition
Non-Small Cell Lung Cancer
Thoracotomy

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Randomized Study of PET/CT in Pre-Operative Staging of Lung Cancer

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Number of futile thoracotomies [ Time Frame: Within 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of thoracotomies and survival [ Time Frame: Within 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 189
Study Start Date: January 2002
Study Completion Date: February 2008
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with non-small cell lung cancer

Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00867412

Locations
Denmark
PET & Cyclotron Unit, Rigshospitalet,
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Danish Cancer Society
Danish Centre for Health Technology Assessment
  More Information

No publications provided by Rigshospitalet, Denmark

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ulrik Lassen, MD., PH.D, Rigshospitalet
ClinicalTrials.gov Identifier: NCT00867412     History of Changes
Other Study ID Numbers: PERALUST
Study First Received: March 20, 2009
Last Updated: March 20, 2009
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Rigshospitalet, Denmark:
NSCLC
PET/CT
Surgery
FDG
staging

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 28, 2014