Clinical trial NCT00579852: Assess the Variability of Uni-Dimensional, Bi-Dimensional, and Volumetric CT Scan Measurement of Non-Small Cell Lung Cancer Tumors
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Non Small Cell
Keywords: Lung
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2007-12-24
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Thoracic Oncology Service at MSKCC clinic.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: To evaluate the reproducibility of calculated volume of pulmonary masses on separate CT scans obtained on the same day in patients with NSCLC
timeFrame: same day, within 30 minutes
Secondary outcomes:
measure: 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
timeFrame: same day, within 30 minutes
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Mark Kris, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1200/JCO.2010.33.7071. Epub 2011 Jul 5.