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The Impact of Positron Emission Tomography (PET) Imaging in Staging Potentially Surgically Resectable Non-small Cell Lung Cancers: A Prospective Multicentre Randomized Clinical Trial


Phase 3
18 Years
N/A
Not Enrolling
Both
Non-small-cell Lung Carcinoma

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Trial Information

The Impact of Positron Emission Tomography (PET) Imaging in Staging Potentially Surgically Resectable Non-small Cell Lung Cancers: A Prospective Multicentre Randomized Clinical Trial


Inclusion Criteria:



- Histological or cytological proof of NSCLC

- Stage I, II, or IIIA NSCLC based upon clinical staging

- The primary lesion appears technically appropriate for surgical resection, based on
information from the chest x-ray (CXR) and CT thorax.

- Age over 18 years

Exclusion Criteria:

- Poor pulmonary function precluding radical surgery (inadequate pulmonary reserve for
radical surgery) with predicted post-resection forced expiratory volume in 1 second
(FEV1) < 0.8 liter or < 40% predicted, and diffusing capacity of the lung for carbon
monoxide (DLCO) < 40% predicted

- Poor performance status (Eastern Cooperative Oncology Group [ECOG] 3-4)

- Significant concurrent medical problems (e.g. uncontrolled diabetes, active cardiac
problems, significant chronic obstructive pulmonary disease) making the patient unfit
for surgery

- Pregnant or lactating females

- Unable to lie supine for imaging with PET

- Patients with previously treated cancer other than non-melanotic skin cancer or
carcinoma in situ of the cervix, unless disease-free for 5 years or greater

- Patients who, at the time of the initial evaluation, have already undergone a whole
body PET/PET-CT, CT brain, MRI brain, total body bone scan or mediastinoscopy within
8 weeks prior to randomization will be excluded. However, patients who have had a CT
scan of the thorax with abdomen are not excluded.

- Failure to provide informed consent

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Patients correctly upstaged by PET versus conventional staging

Outcome Time Frame:

November 2007

Safety Issue:

No

Principal Investigator

Donna E Maziak, MD

Investigator Role:

Study Chair

Investigator Affiliation:

The Ottawa Hospital

Authority:

Canada: Health Canada

Study ID:

CTA-Control-088145

NCT ID:

NCT00136890

Start Date:

July 2004

Completion Date:

January 2013

Related Keywords:

  • Non-Small-Cell Lung Carcinoma
  • Positron-Emission Tomography
  • PET Scan
  • Lung Cancer
  • Thoracic Surgery
  • Diagnostic
  • Randomized Controlled Trial
  • Oncology
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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