CTP Imaging of Lung Cancer (CTPLC)

January 22, 2016 updated by: University of California, Davis

CTP (Computed Tomography Perfusion) Imaging of Lung Cancer

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 Overview

Status

Completed

Conditions

Non Small Cell Lung Cancer

Detailed 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.

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- California
  - Sacramento, California, United States, 95817
    - University of California, Davis Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with non small cell lung cancer who are planned to receive systemic therapy

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Variability of measurements variability of CTP measurements will be determined by repeating the CTP examination, and comparing the resultant blood flow estimates
Treatment induced effects The magnitude of treatment induced effects will be assessed by comparing tumor blood flow estimates before and after treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Yield of conducting CTP studies Time Frame: 2 years	Yield is determined as the percentage of assessable CTP studies, relative to all performed studies	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Variability of CTP measurements Time Frame: 2 years	Variability will be determined from two consecutively acquired CTP examinations, and repeated analyses of the same studies	2 years
Magnitude of treatment induced changes in tumor blood flow Time Frame: 2 years	The magnitude of treatment induced changes in blood flow will be determined from comparisons of bloodflow before and after treatment	2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Collaborators

Radiological Society of North America

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

March 22, 2013

First Submitted That Met QC Criteria

March 28, 2013

First Posted (Estimate)

April 4, 2013

Study Record Updates

Last Update Posted (Estimate)

January 26, 2016

Last Update Submitted That Met QC Criteria

January 22, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

393991

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.