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

NCT ID: NCT00613041

Last Updated: 2023-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

19 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-04-30

Study Completion Date

2021-11-03

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.

Detailed Description

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Conditions

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Undiagnosed Pulmonary Nodules Lung Nodules

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

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

CT Scan

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marc Feinstein, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Countries

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United States

Related Links

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http://www.mskcc.org

Memorial Sloan-Kettering Cancer Center

Other Identifiers

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03-039

Identifier Type: -

Identifier Source: org_study_id

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