Trial Information

Evolution of Undetermined Ld-CT Detected Lung Nodules Among a Randomized Phase II Trial With Inhaled Budesonide

OBJECTIVES:

Primary

- Evaluation of lung nodules (target and non-target lesions) detected during annual
low-dose (ld) computed tomography (CT) scans and measured for three years after study
completion in subjects enrolled in a randomized, phase IIb, placebo-controlled trial
with inhaled budesonide (both person-specific and lesion-specific analyses will be
performed).

Secondary

- Lung cancer detection rate in the two arms.

- Appearance of new nodules in the two arms.

OUTLINE: Low-dose CT scans are analyzed retrospectively for the natural progression of
undetermined lung nodules. Nodule dimension will be evaluated according to maximum diameter
and volume, when feasible. Volume measurements are performed using an automatic and
semi-automatic computer-aided diagnosis (CAD) system. Lesion-specific and person-specific
analysis are performed by measure of average change in size of the target lesions or number
of lesions.