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PET Imaging in Potentially Surgically Resectable Non-small Cell Lung Cancers

NCT00136890 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 337

Last updated 2013-01-15

No results posted yet for this study

Summary

Lung cancer remains the leading cause of cancer deaths in men and women. Although overall survival remains poor, early stage non-small cell lung cancer (NSCLC) is potentially curable. Improved staging has led to stage-specific therapies such that patients with early stage NSCLC are potential candidates for surgical resection, and those with more advanced disease are spared the morbidity and risk of mortality from thoracotomy and pulmonary resection. Despite contemporary staging techniques, 25-50% of patients who appear to have limited disease amenable to surgical resection go on to die from metastatic lung cancer. If occult micro-metastatic disease that becomes evident later could be detected reliably during the pre-operative assessment, patients harboring such disease could be spared a non-curative thoracotomy. PET imaging has the potential to detect mediastinal and extrathoracic metastatic disease not detected by conventional imaging modalities.

This prospective, multicenter trial will enroll patients with biopsy-proven clinical stage I-IIIA NSCLC who are considered to be candidates for surgical resection with curative intent. Preoperatively, patients will be randomized to conventional staging for metastatic disease (CT liver/adrenals, total body bone scan, and CT with contrast or MRI with gadolinium of the brain) versus whole body PET or PET-CT and brain CT or MRI with contrast/gadolinium.

Conditions

  • Non-small-cell Lung Carcinoma

Interventions

PROCEDURE

PET Imaging

Patients randomized to PET staging will undergo FDG-PET or PET-CT as well as some form of cranial imaging (CT or MRI)

Sponsors & Collaborators

  • Ontario Ministry of Health and Long Term Care

    collaborator OTHER_GOV

  • Ontario Clinical Oncology Group (OCOG)

    lead OTHER

Principal Investigators

  • Donna E Maziak, MD · The Ottawa Hospital

  • Gail E Darling, MD · Toronto General Hospital

  • Mark N Levine, MD · Ontario Clinical Oncology Group (OCOG)

  • William Evans, MD · Juravinski Cancer Centre

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-07-31
Primary Completion
2008-11-30
Completion
2013-01-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00136890 on ClinicalTrials.gov