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

Lung Nodules Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00613041
• Other study ID #: 03-039
• Status: Completed
• Start date: April 2003
• Est. completion date: November 3, 2021

Study information

• Verified date: September 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: November 3, 2021
• Est. primary completion date: November 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Nodules
• Multiple Pulmonary Nodules
• Undiagnosed Pulmonary Nodules

Intervention

Procedure:
• CT Scan
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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To determine three-dimensional characteristics of pulmonary nodules which may discriminate between benign and malignant diseases.		conclusion of the study

External Links

•   Memorial Sloan-Kettering Cancer Center