Expired Study
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Sacramento, California 95817


Purpose:

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.


Study summary:

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.


Criteria:

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 is Available At:


Original ID:

393991


NCT ID:

NCT01823094


Secondary ID:


Study Acronym:

CTPLC


Brief Title:

CTP Imaging of Lung Cancer


Official Title:

CTP (Computed Tomography Perfusion) Imaging of Lung Cancer


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of California, Davis


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Case-Only, Time Perspective:


Number of Arms:

0


Number of Groups:

2


Total Enrollment:

14


Enrollment Type:

Actual


Overall Contact Information

Official Name:Friedrich Knollmann, MD, PhD
Principal Investigator
Univeristy of California, Davis

Study Dates

Start Date:March 2013
Completion Date:June 2015
Completion Type:Actual
Primary Completion Date:June 2015
Primary Completion Type:Actual
Verification Date:January 2016
Last Changed Date:January 22, 2016
First Received Date:March 22, 2013

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Magnitude of treatment induced changes in tumor blood flow
Time Frame:2 years
Safety Issues:False
Description:The magnitude of treatment induced changes in blood flow will be determined from comparisons of bloodflow before and after treatment
Outcome Type:Secondary Outcome
Measure:Variability of CTP measurements
Time Frame:2 years
Safety Issues:False
Description:Variability will be determined from two consecutively acquired CTP examinations, and repeated analyses of the same studies
Outcome Type:Primary Outcome
Measure:Yield of conducting CTP studies
Time Frame:2 years
Safety Issues:False
Description:Yield is determined as the percentage of assessable CTP studies, relative to all performed studies

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:Treatment induced effects
Description:The magnitude of treatment induced effects will be assessed by comparing tumor blood flow estimates before and after treatment
Study Arm Type:Other
Arm Name:Variability of measurements
Description:variability of CTP measurements will be determined by repeating the CTP examination, and comparing the resultant blood flow estimates

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of California, Davis
Agency Class:Other
Agency Type:Collaborator
Agency Name:Radiological Society of North America

Samples and Retentions

Study Population: patients with non small cell lung cancer who are planned to receive systemic therapy
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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