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
  Purpose

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: April 2003
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00613041

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

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00613041     History of Changes
Other Study ID Numbers: 03-039
Study First Received: January 29, 2008
Last Updated: December 3, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 20, 2014