Lung Cancer
Conditions
Brief summary
The purpose of this study is to determine whether giving an anti-inflammatory medication (corticosteroid) prior to a positron emission tomography scan (PET) scan may reduce or eliminate false findings related to inflammation
Detailed description
PRIMARY OBJECTIVES: I. To assess whether premedication with a corticosteroid may reduce false positive findings on fluorodeoxyglucose (fludeoxyglucose F 18 \[FDG\[) PET/computed tomography (CT) scans in lung cancer patients, by reducing radiotracer uptake in thoracic lymph nodes related to inflammation. OUTLINE: Within 1-14 days of undergoing standard FDG PET/CT scan, patients receive methylprednisolone intravenously (IV) and then undergo a second FDG PET/CT scan. After completion of study treatment, patients are followed up for 2 years.
Interventions
DRUGmethylprednisolone
Given IV
RADIATIONfludeoxyglucose F 18
Undergo FDG PET/CT scan
PROCEDUREpositron emission tomography
Undergo FDG PET/CT scan
PROCEDUREcomputed tomography
Undergo FDG PET/CT scan
Sponsors
Ohio State University Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient undergoing initial staging of biopsy proven lung cancer (all cancer stages included) * Undergone clinical FDG PET/CT scan within 14 days of enrollment
Exclusion criteria
* Prisoners * Diabetic patients (on insulin, on oral hypoglycemic, or fasting glucose \> 180 mg/dl) * Serious infection within 14 days of enrollment * Known hypersensitivity to methylprednisolone * Viral skin lesions * Immunocompromised ANC(absolute neutrophil count \< 1000/microliter) * Pregnant/nursing * History of tuberculosis or systemic fungal disease * History of steroid psychosis * Current peptic ulcer disease or diverticulitis * Corticosteroid use within 14 days of enrollment (including inhaled steroids)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Continuous standardized uptake values (SUV) | Within 1-14 days of first scan | The SUV on the first and second PET scans will be recorded and summarized on a receiver operating characteristic (ROC) curve. We will explore the ROC curve for percent change in SUV or uptake ratio from the first to the second scan. We will explore thresholds for SUV and uptake values on the ROC curve by determining the values of acceptable combinations of true positive fractions (TPF) and false positive fractions (FPFs). We will use regression methods to adjust for possible confounding patient demographics, disease severity and disease history. |
Outcome results
None listed