Non Small Cell Lung CancerCTPLCNCT01823094
CTP Imaging of Lung Cancer
An observational study of Non Small Cell Lung Cancer, run by University of California, Davis at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with non small cell lung cancer who are planned to receive systemic therapy
Who may be able to join
- adult patients with non small cell lung cancer who receive, or are considered for, systemic therapy
Who cannot join
- renal failure pregnancy known contrast allergy
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis Medical Center
Sacramento, California, 95817
About this study
Official title: 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.
Read the 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.
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- lung cancer, computed tomography, blood flow
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Yield of conducting CTP studies
Yield is determined as the percentage of assessable CTP studies, relative to all performed studies
Measured: 2 years
Secondary outcomes (2)
Variability of CTP measurements
Variability will be determined from two consecutively acquired CTP examinations, and repeated analyses of the same studies
Measured: 2 years
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Radiological Society of North America
- Responsible party
- Sponsor
- Investigators
- Friedrich Knollmann, MD, PhD, Principal investigator, Univeristy of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01823094
- Sponsor's protocol ID
- 393991
- Acronym
- CTPLC
- Status last verified
- Jan 2016
- First submitted
- 22 Mar 2013
- Last updated
- 26 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CTP (Computed Tomography Perfusion) Imaging of Lung Cancer
- ClinicalTrials.gov ID
- NCT01823094
- Acronym / sponsor ID
- CTPLC / 393991
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- lung cancer, computed tomography, blood flow
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Radiological Society of North America
- Study start
- Mar 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 4 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with non small cell lung cancer who are planned to receive systemic therapy
Key inclusion criteria (1 listed)
- adult patients with non small cell lung cancer who receive, or are considered for, systemic therapy
Key exclusion criteria (2 listed)
- renal failure pregnancy known contrast allergy
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 secondary outcomes
Variability of CTP measurements
Time frame: 2 years
Magnitude of treatment induced changes in tumor blood flow
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Friedrich Knollmann, MD, PhD principal investigator
Univeristy of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Small Cell Lung Cancer, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Yield of conducting CTP studies (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2016.