Lung CancerNCT00643370
Quantifying Lung Tumor Movement Under Deep Inspiration Breath Holds
An observational study of Lung Cancer, run by AHS Cancer Control Alberta at 1 site in Canada.
Trial summary
Radiotherapy is a common treatment for lung cancer. One Challenge of delivering radiation treatment to lung tumors accurately is tumor movement which occurs as a patient breathes. In some situations, tumors move enough during breathing so that some or all of the tumor may be missed by a radiation treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- CT scan of the chest under deep inspiration breath hold
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2008to Jan 2011
- 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 any primary lung cancer who are undergoing radiotherapy or chemoradiotherapy
Who may be able to join
- biopsy confirmed primary lung cancer
- undergoing radiotherapy or chemoradiotherapy
- able to perform adequate deep inspiration breath hold
- patients of childbearing potential must practice adequate contraception
- signed study-specific informed consent form
Who cannot join
- unable to perform adequate deep inspiration breath hold
- prior tumor resection
- prior chest or neck RT
- pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quantifying Lung Tumor Movement Under Dep Inspiration Breath Holds
Radiotherapy is a common treatment for lung cancer. One Challenge of delivering radiation treatment to lung tumors accurately is tumor movement which occurs as a patient breathes. In some situations, tumors move enough during breathing so that some or all of the tumor may be missed by a radiation treatment. One way to decrease the amount a lung tumor moves during radiotherapy treatments is for patients to held their breath briefly during a radiation treatment. By doing this, a patient's lung tumor may not move as much as it would during regular breathing. In this study, the investigators aim to study patients with lung cancers which move during breathing. Patients will be asked to hold their breath after inspiration while a CT scan of their lung tumor is obtained. The purpose of this study is to study how much less patients' lung tumors move when they hold their breath
- Conditions
- Lung Cancer
- Being tested
- CT scan of the chest under deep inspiration breath hold
- Keywords
- lung cancer, tumor motion
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT scan of the chest under deep inspiration breath holdOther
computed tomography scan of the chest under dep inspiration breath hold conditions
| Study group | Role | What they receive |
|---|---|---|
| 1 | single arm study Receives: Other: CT scan of the chest under deep inspiration breath hold |
What is being measured
The primary outcome is the main question the study is designed to answer.
tumor movement
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2008 (estimated)
- Study startApr 2008
- Primary completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Cross Cancer Institute
- Responsible party
- Sponsor
- Investigators
- Don Yee, MD, FRCPC, Principal investigator, AHS Cancer Control Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00643370
- Sponsor's protocol ID
- LU-23980
- Status last verified
- Aug 2011
- First submitted
- 24 Mar 2008
- Last updated
- 17 Feb 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantifying Lung Tumor Movement Under Dep Inspiration Breath Holds
- ClinicalTrials.gov ID
- NCT00643370
- Acronym / sponsor ID
- LU-23980
- Conditions
- Lung Cancer
- Keywords
- lung cancer, tumor motion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- Collaborators
- Cross Cancer Institute
- Study start
- Apr 2008
- Primary completion
- Jan 2011 (actual)
- First posted
- 26 Mar 2008 (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.
Radiotherapy is a common treatment for lung cancer. One Challenge of delivering radiation treatment to lung tumors accurately is tumor movement which occurs as a patient breathes. In some situations, tumors move enough during breathing so that some or all of the tumor may be missed by a radiation treatment. One way to decrease the amount a lung tumor moves during radiotherapy treatments is for patients to held their breath briefly during a radiation treatment. By doing this, a patient's lung tumor may not move as much as it would during regular breathing. In this study, the investigators aim to study patients with lung cancers which move during breathing. Patients will be asked to hold their breath after inspiration while a CT scan of their lung tumor is obtained. The purpose of this study is to study how much less patients' lung tumors move when they hold their breath
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: CT scan of the chest under deep inspiration breath holdsingle arm study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with any primary lung cancer who are undergoing radiotherapy or chemoradiotherapy
Key inclusion criteria (5 listed)
- biopsy confirmed primary lung cancer
- undergoing radiotherapy or chemoradiotherapy
- able to perform adequate deep inspiration breath hold
- patients of childbearing potential must practice adequate contraception
- signed study-specific informed consent form
Key exclusion criteria (4 listed)
- unable to perform adequate deep inspiration breath hold
- prior tumor resection
- prior chest or neck RT
- pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT scan of the chest under deep inspiration breath holdcomputed tomography scan of the chest under dep inspiration breath hold conditions | Other | 1 |
Primary outcome
tumor movement
Time frame: 12 months
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 17 Feb 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.
Don Yee, MD, FRCPC principal investigator
AHS Cancer Control Alberta
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 Lung Cancer, run by AHS Cancer Control Alberta at 1 site in Canada.
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 5 inclusion and 4 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 17 Feb 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 Canada. 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?
tumor movement (time frame: 12 months). 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 17 Feb 2016.