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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center Identifier:
First received: January 29, 2008
Last updated: September 26, 2016
Last verified: September 2016

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 Intervention
Undiagnosed Pulmonary Nodules
Lung Nodules
Procedure: CT Scan

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Memorial Sloan Kettering Cancer Center:

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

Enrollment: 19
Study Start Date: April 2003
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center Identifier: NCT00613041     History of Changes
Other Study ID Numbers: 03-039
Study First Received: January 29, 2008
Last Updated: September 26, 2016

Additional relevant MeSH terms:
Multiple Pulmonary Nodules
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases processed this record on April 27, 2017