3-D Reconstruction of CT Scan Images in the Evaluation of Non-Specific Pulmonary Nodules

Study Overview
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Brief Summary
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In recent years, more and more people are having lung CT scans performed to screen for various cancers. Many of them have small abnormalities detected, called nodules, which - for a variety of reasons - doctors are unable to biopsy. As a result, many patients have their CT scans repeated on a regular basis to see if their nodules grow. This process can last several years. Many patients experience significant anxiety during this process, when they are aware of a spot in the lung, but are not told any specific cause. Researchers at Memorial Sloan-Kettering have developed a new way to look at lung nodules in three dimensions. The purpose of this project is to see if any change in the nodules can be detected sooner by this method than by traditional CT scans.

Official Title
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Pilot Study: 3-D Reconstruction of CT Scan Images in the Evaluation of Non-Specific Pulmonary Nodules

Conditions
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Undiagnosed Pulmonary Nodules, Lung Nodules

Intervention / Treatment
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* Procedure: CT Scan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Referral to the pulmonary or thoracic surgery service for undiagnosed pulmonary nodules. History of smoking exceeding 10 pack-years (pack year defined as number of packs of cigarettes per day multiplied by the number of years smoked). Age >18 Nodule size 5 to 15 mm in diameter. Exclusion Criteria: Clinical indication for immediate biopsy via bronchoscopy, fine needle aspiration, or video-assisted thoracoscopic Surgery (VATS) Active lung cancer or metastasis to the lung. Contraindication to needle biopsy. Pneumonectomy Need for supplemental oxygen. Radiation pneumonitis Interstitial lung disease.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Patients with one or more pulmonary nodules 5-15 mm in diameter. | Procedure: CT Scan<br>* All patients will undergo serial CT scans after 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months as is standard care. Nodules are to be scanned at 2.5mm collimation / 1.25 mm reconstruction. This resolution is necessary for volume measurements of nodules less than 1cm in diameter.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To collect preliminary data regarding the comparative sensitivity and specificity of conventional CT scan and three-dimensional CT for detecting the growth of nonspecific pulmonary nodules. |  | conclusion of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine three-dimensional characteristics of pulmonary nodules which may discriminate between benign and malignant diseases. |  | conclusion of the study |