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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00613041
Recruitment Status : Active, not recruiting
First Posted : February 12, 2008
Last Update Posted : September 6, 2017
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Undiagnosed Pulmonary Nodules Lung Nodules Procedure: CT Scan

Study Type : Observational
Actual Enrollment : 19 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study: 3-D Reconstruction of CT Scan Images in the Evaluation of Non-Specific Pulmonary Nodules
Study Start Date : April 2003
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Patients with one or more pulmonary nodules 5-15 mm in diameter.
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.

Primary Outcome Measures :
  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. [ Time Frame: conclusion of the study ]

Secondary Outcome Measures :
  1. To determine three-dimensional characteristics of pulmonary nodules which may discriminate between benign and malignant diseases. [ Time Frame: conclusion of the study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00613041

United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Principal Investigator: Marc Feinstein, MD Memorial Sloan Kettering Cancer Center

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center Identifier: NCT00613041     History of Changes
Other Study ID Numbers: 03-039
First Posted: February 12, 2008    Key Record Dates
Last Update Posted: September 6, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Multiple Pulmonary Nodules
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases