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

NCT ID: NCT00579852

Last Updated: 2008-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

37 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-11-30

Study Completion Date

2008-01-31

Brief Summary

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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

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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.

Conditions

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Lung Cancer Non Small Cell

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

CT Scan

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Memorial Sloan-Kettering Cancre Center

Principal Investigators

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Mark Kris, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 21730273 (View on PubMed)

Related Links

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http://www.mskcc.org

Memorial Sloan-Kettering Cancer Center

Other Identifiers

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06-149

Identifier Type: -

Identifier Source: org_study_id

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