NCT01540552

Natural History of Lung Nodules Seen on CT Scans From Participants at High-Risk of Developing Lung Cancer

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 320 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Comparing lung CT scans from participants with lung nodules at high-risk for lung cancer may help doctors learn more about the disease and find better methods of treatment. PURPOSE: This trial studies the natural history of lung nodules using CT scans from participants at high-risk for lung cancer.

Detailed description

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.

Conditions

• Lung Cancer
• Precancerous Condition

Interventions

Type	Name	Description
OTHER	medical chart review
PROCEDURE	computed tomography
PROCEDURE	computer-aided detection/diagnosis

Timeline

• Start date: 2012-02-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2012-02-29
• Last updated: 2013-01-25

Locations

1 site across 1 country: Italy