Clinical trial · Interventional
Methylprednisolone Before Fludeoxyglucose-Labeled Positron Emission Tomography in Patients With Lung Cancer
FDG PET/CT: Reducing False Positive Mediastinal Uptake by Premedicating With Methylprednisolone
NCT01789892CI-TRIAL-00033504withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): no patient accrual
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| computed tomography | Procedure | — | UNRESOLVED |
| fludeoxyglucose F 18 | Radiation | — | UNRESOLVED |
| methylprednisolone | Drug | — | UNRESOLVED |
| positron emission tomography | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (methylprednisolone and FDG PET/CT scan)
- description
- Within 1-14 days of undergoing standard FDG PET/CT scan, patients receive methylprednisolone IV and then undergo a second FDG PET/CT scan.
- interventionNames
- Drug: methylprednisolone
- Radiation: fludeoxyglucose F 18
- Procedure: positron emission tomography
- Procedure: computed tomography
Primary outcomes (1)
- measure
- Continuous standardized uptake values (SUV)
- timeFrame
- Within 1-14 days of first scan
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.