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

NCT00613041 | Completed

• 1 other identifier: 03-039
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Undiagnosed Pulmonary Nodules; Lung Nodules

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To determine three-dimensional characteristics of pulmonary nodules which may discriminate between benign and malignant diseases.

  conclusion of the study

Study Arms (1)

1

Patients with one or more pulmonary nodules 5-15 mm in diameter.

Procedure: CT Scan

Interventions

CT Scan PROCEDURE

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.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who meet eligibility criteria will be recruited from the services that comprise the Thoracic Disease Management Team (DMT), specifically the Divisions of Pulmonary Medicine and Thoracic Surgery.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

Study Officials

• Marc Feinstein, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2008
• First Posted: February 12, 2008
• Study Start: April 1, 2003
• Primary Completion: November 3, 2021
• Study Completion: November 3, 2021
• Last Updated: September 13, 2023

Record last verified: 2023-09

Locations

US (1)