NCT01823094

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2013

Typical duration for all trials

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

March 1, 2013

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

March 22, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 4, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

January 26, 2016

Status Verified

January 1, 2016

Enrollment Period

2.3 years

First QC Date

March 22, 2013

Last Update Submit

January 22, 2016

Conditions

Non Small Cell Lung Cancer

Keywords

lung cancercomputed tomographyblood flow

Outcome Measures

Primary Outcomes (1)

  • Yield of conducting CTP studies

    Yield is determined as the percentage of assessable CTP studies, relative to all performed studies

    2 years

Secondary Outcomes (2)

  • Variability of CTP measurements

    2 years

  • Magnitude of treatment induced changes in tumor blood flow

    2 years

Study Arms (2)

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

Eligibility Criteria

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

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

You may qualify if:

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

You may not qualify if:

  • renal failure pregnancy known contrast allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Davis Medical Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungLung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Friedrich Knollmann, MD, PhD

    Univeristy of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 22, 2013

First Posted

April 4, 2013

Study Start

March 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

January 26, 2016

Record last verified: 2016-01

Locations

US(1)