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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01823094
Other study ID # 393991
Secondary ID
Status Completed
Phase N/A
First received March 22, 2013
Last updated January 22, 2016
Start date March 2013
Est. completion date June 2015

Study information

Verified date January 2016
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

Investigators hope to learn more about how to use computed tomography (CT) scans to measure blood flow in lung tumors and how it may change in response to treatment. This measurement technique is called computed tomography perfusion (CTP). CT scanners use X-rays to produce 3-dimensional images of the body.

Currently, doctors determine the response to treatment by measuring the size of the tumor. Investigators are trying to find out if measuring the blood flow in the tumor is equal to or better than measuring the size of the tumor.


Description:

This is an experimental study of CT perfusion (CTP) imaging in subjects with non-small cell lung cancer. The objectives of this study are to demonstrate the feasibility of CT blood flow measurements in lung cancer, to develop a foundation for the use of CT blood flow measurements in lung cancer to assess the response to treatment, and to develop an optimized CTP imaging protocol for evaluating blood flow in solid body tumors. In this study, tumor blood flow will be evaluated at baseline and follow-up routine CT examinations of patients with non-small cell lung cancer, and the response of tumor blood flow will be recorded as a secondary endpoint. This research study will entail two study visits - one required and one optional - which will coincide with regularly scheduled standard of care CT scans.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

adult patients with non small cell lung cancer who receive, or are considered for, systemic therapy

Exclusion Criteria:

renal failure pregnancy known contrast allergy

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Locations

Country Name City State
United States University of California, Davis Medical Center Sacramento California

Sponsors (2)

Lead Sponsor Collaborator
University of California, Davis Radiological Society of North America

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Yield of conducting CTP studies Yield is determined as the percentage of assessable CTP studies, relative to all performed studies 2 years No
Secondary Variability of CTP measurements Variability will be determined from two consecutively acquired CTP examinations, and repeated analyses of the same studies 2 years No
Secondary Magnitude of treatment induced changes in tumor blood flow The magnitude of treatment induced changes in blood flow will be determined from comparisons of bloodflow before and after treatment 2 years No
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