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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00613041
First received: January 29, 2008
Last updated: December 3, 2013
Last verified: December 2013

January 29, 2008
December 3, 2013
April 2003
August 2014   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00613041 on ClinicalTrials.gov Archive Site
To determine three-dimensional characteristics of pulmonary nodules which may discriminate between benign and malignant diseases. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
3-D Reconstruction of CT Scan Images in the Evaluation of Non-Specific Pulmonary Nodules
Pilot Study: 3-D Reconstruction of CT Scan Images in the Evaluation of Non-Specific Pulmonary Nodules

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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.

  • Undiagnosed Pulmonary Nodules
  • Lung Nodules
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.
1
Patients with one or more pulmonary nodules 5-15 mm in diameter.
Intervention: Procedure: CT Scan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
19
August 2014
August 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00613041
03-039
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Not Provided
Principal Investigator: Marc Feinstein, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP