Assess the Variability of Uni-Dimensional, Bi-Dimensional, and Volumetric CT Scan Measurement of Non-Small Cell Lung Cancer Tumors

This study has been completed.
Sponsor:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00579852
First received: December 20, 2007
Last updated: January 31, 2008
Last verified: January 2008

December 20, 2007
January 31, 2008
November 2006
January 2008   (final data collection date for primary outcome measure)
To evaluate the reproducibility of calculated volume of pulmonary masses on separate CT scans obtained on the same day in patients with NSCLC [ Time Frame: same day, within 30 minutes ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00579852 on ClinicalTrials.gov Archive Site
To evaluate the reproducibility of bidimensional and unidimensional measurement of pulmonary masses on separate CT scans obtained on the same day in patients with NSCLC [ Time Frame: same day, within 30 minutes ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Assess the Variability of Uni-Dimensional, Bi-Dimensional, and Volumetric CT Scan Measurement of Non-Small Cell Lung Cancer Tumors
A Prospective Trial to Assess the Variability of Uni-Dimensional, Bi-Dimensional, and Volumetric CT Scan Measurement of Non-Small Cell Lung Cancer Tumors

The purpose of this study is to compare the results of two CT scans of the chest performed within minutes of each other. We will compare several different measurements of lung cancer tumors. This study will help show whether we can get accurate results when we compare measurements on different CT scans. This information is important for patients with cancer, who often have more than one CT scan during their treatment.

Standard criteria for tumor response assessment have used uni-dimensional or bi-dimensional measurements as a surrogate for volume determination. Modern CT scan techniques, in combination with algorithms developed at MSKCC, allow the calculation of tumor volume. This protocol is designed to evaluate the reproducibility of the calculated volume of pulmonary masses on separate CT scans obtained on the same day in patients with non-small cell lung cancer (NSCLC). Patients with NSCLC undergoing non-contrast CT scan of the chest will have a second, non-contrast CT scan of the chest performed. Uni-dimensional, bi-dimensional, and volume measurements for the primary NSCLC lesion will be determined on both scans and the values compared.

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

Thoracic Oncology Service at MSKCC clinic.

  • Lung Cancer
  • Non Small Cell
Procedure: CT Scan
Patients with NSCLC undergoing non-contrast CT scan of the chest will have a second, high resolution, non-contrast CT scan of the chest performed on the same day. The scans will be performed on the same CT scanner, generally within 30 minutes. Unidimensional, bi-dimensional, and volume measurements for the primary NSCLC lesion will be determined on both scans and the values compared. After completing the second scan, the patient will have completed participation in the protocol.
1
Patients with NSCLC undergoing non-contrast CT scan of the chest will have a second, high resolution, non-contrast CT scan of the chest performed on the same day.
Intervention: Procedure: CT Scan
Oxnard GR, Zhao B, Sima CS, Ginsberg MS, James LP, Lefkowitz RA, Guo P, Kris MG, Schwartz LH, Riely GJ. Variability of lung tumor measurements on repeat computed tomography scans taken within 15 minutes. J Clin Oncol. 2011 Aug 10;29(23):3114-9. Epub 2011 Jul 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
January 2008
January 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Have pathologically confirmed non-small cell lung cancer
  • Have measurable primary pulmonary tumors ≥ 1cm
  • Have plans for a clinically indicated non-contrast CT scan of the chest
  • All patients must be ≥ 18 years old

Exclusion Criteria:

  • Pregnant or lactating women
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00579852
06-149
Not Provided
Mark Kris, MD, Memorial Sloan-Kettering Cancre Center
Memorial Sloan-Kettering Cancer Center
Not Provided
Principal Investigator: Mark Kris, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
January 2008

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