NCT00579852

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 24, 2007

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

February 1, 2008

Status Verified

January 1, 2008

Enrollment Period

1.2 years

First QC Date

December 20, 2007

Last Update Submit

January 31, 2008

Conditions

Keywords

Lung

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • 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

Study Arms (1)

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.

Procedure: CT Scan

Interventions

CT ScanPROCEDURE

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Thoracic Oncology Service at MSKCC clinic.

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Mark Kris, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 20, 2007

First Posted

December 24, 2007

Study Start

November 1, 2006

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

February 1, 2008

Record last verified: 2008-01

Locations