[18F]FDG-PET/CT as a Predictive Marker of Tumor Response and Patient Outcome: Prospective Validation in Non-Small Cell Lung Cancer
- Determine whether a metabolic response, defined as a 25% decrease in peak tumor
standardized uptake value (SUV) after the first course of chemotherapy, provides early
prediction of treatment outcome (tumor response and patient survival) in patients with
stage IIIB or IV non-small cell lung cancer undergoing platinum-based chemotherapy.
- Determine the test-retest reproducibility of quantitative assessment of tumor
fludeoxyglucose F 18 (^18FDG) uptake in these patients.
- Determine the time course of treatment-induced changes in tumor ^18FDG uptake in these
- Determine, in an exploratory analysis, changes in tumor volume during chemotherapy by
multislice CT scanning in these patients.
OUTLINE: This is a prospective, multicenter study. Patients are assigned to 1 of 3 groups.
- Group I: Patients undergo fludeoxyglucose F 18 (^18FDG) positron emission tomography
(PET)/CT scanning twice and 1-2 volumetric CT scanning (1-7 days apart) before starting
treatment with platinum-based chemotherapy. Patients undergo additional ^18FDG PET/CT
scan and a volumetric CT scan once between the first and second course of chemotherapy.
- Group II: Patients undergo ^18FDG PET/CT scan and volumetric CT scanning once before
starting treatment with platinum-based chemotherapy. Patients undergo additional ^18FDG
PET/CT scan and volumetric CT scanning once between the first and second course of
chemotherapy, and may undergo once between the second and third course of chemotherapy.
- Group III: Patients undergo ^18FDG PET/CT scanning twice (up to 1 week apart) before
starting any treatment.
In groups I and II, patients also undergo standard follow-up CT scanning every 6 weeks
(i.e., every other chemotherapy course) for up to 18 weeks.
After completion of chemotherapy, patients are followed every 3 months for up to 1 year.
- Imaging: See
- provided by American College of Radiology Network.
PROJECTED ACCRUAL: A total of 285 patients will be accrued for this study.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Prediction of 1-year overall survival as measured by monitoring changes in tumor metabolic response during the first course of chemotherapy
Wolfgang Weber, MD
Jonsson Comprehensive Cancer Center
United States: Federal Government
|Jonsson Comprehensive Cancer Center at UCLA||Los Angeles, California 90095-1781|