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

Completed

• Conditions: Lung Nodules; Undiagnosed Pulmonary Nodules
• Interventions: Procedure: CT Scan

• Registration Number: NCT00613041
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-04
• Study First Submitted: 2008-01-29
• Study First Submitted QC: 2008-01-29
• Study First Posted: 2008-02-12
• Primary Completion: 2021-11-03
• Study Completion: 2021-11-03
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-11
• Last Update Posted: 2023-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	CT Scan	Patients with one or more pulmonary nodules 5-15 mm in diameter.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
To determine three-dimensional characteristics of pulmonary nodules which may discriminate between benign and malignant diseases.	conclusion of the study

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States