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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00867412
Recruitment Status : Completed
First Posted : March 23, 2009
Last Update Posted : March 23, 2009
Sponsor:
Collaborators:
Danish Cancer Society
Danish Centre for Health Technology Assessment
Information provided by:
Rigshospitalet, Denmark

Tracking Information
First Submitted Date March 20, 2009
First Posted Date March 23, 2009
Last Update Posted Date March 23, 2009
Study Start Date January 2002
Actual Primary Completion Date February 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 20, 2009)
Number of futile thoracotomies [ Time Frame: Within 1 year ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: March 20, 2009)
Number of thoracotomies and survival [ Time Frame: Within 1 year ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Randomized Study of Positron Emission Tomography - Computed Tomography (PET/CT) in Pre-Operative Staging of Lung Cancer
Official Title Randomized Study of PET/CT in Pre-Operative Staging of Lung Cancer
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.
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
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with non-small cell lung cancer
Condition
  • Non-Small Cell Lung Cancer
  • Thoracotomy
Intervention Not Provided
Study 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 20, 2009)
189
Original Actual Enrollment Same as current
Actual Study Completion Date February 2008
Actual Primary Completion Date February 2007   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT00867412
Other Study ID Numbers PERALUST
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Ulrik Lassen, MD., PH.D, Rigshospitalet
Study Sponsor Rigshospitalet, Denmark
Collaborators
  • Danish Cancer Society
  • Danish Centre for Health Technology Assessment
Investigators Not Provided
PRS Account Rigshospitalet, Denmark
Verification Date March 2009