Diagnosis of early stage lung cancer in a population that have a single pulmonary nodule detected by conventional CT scan Cancer Malignant neoplasm of bronchus and lung
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. A soft tissue solitary dominant pulmonary nodule of = 8mm and = 30mm on axial plane, measured on lung window using conventional CT scan with no other ancillary evidence strongly indicative of malignancy (e.g. distant metastases) or unequivocal local invasion. 2. 18 years of age or over at time of providing consent 3. Able and willing to consent to study
Exclusion criteria
Exclusion criteria: 1. Pregnancy 2. History of malignancy within the past 2 years 3. Confirmed aetiology of the nodule 4. Biopsy of nodule prior to DCE-CT scan 5. Contra-indication to potential radiotherapy or surgery 6. Contra indication to scans (assessed by local procedures)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Diagnostic test characteristics of sensitivity, specificity and accuracy for both FDG-PET/CT and DCE-CT scans in relation to a subsequent clinical diagnosis of lung cancer. 2. Economic model will include accuracy, estimated life expectancy, and quality adjusted life years (QALYs) 3. Costs will be estimated from an NHS perspective. Incremental cost-effectiveness ratios will compare management strategies with DCE-CT to strategies without DCE-CT. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Diagnostic test characteristics for FDG-PET/CT with incorporation of CT appearances and combined DCE-CT/FDG-PET scans. 2. Incidence of incidental extra-thoracic findings on FDG-PET/CT and subsequent investigations and costs will also be determined. | — |
Countries
England, United Kingdom