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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00579852
• Other study ID #: 06-149
• Status: Completed
• Phase: N/A
• First received: December 20, 2007
• Last updated: January 31, 2008
• Start date: November 2006
• Est. completion date: January 2008

Study information

• Verified date: January 2008
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms
• Non Small Cell

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the reproducibility of calculated volume of pulmonary masses on separate CT scans obtained on the same day in patients with NSCLC		same day, within 30 minutes	No
Secondary	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		same day, within 30 minutes	No

External Links

•   Memorial Sloan-Kettering Cancer Center