Lung CancerPhase 1NCT00188162
Minimum Dose CT Post Lung Biopsy
A Phase 1 study testing CT in people with Lung Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The aim is to evaluate whether Minimum Dose CT (MnDCT) is useful in the management of patients post Lung Biopsy Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- CT
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2004to Sep 2005
- Phase
- Phase 1
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All Patients having a lung biopsy
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Minimum Dose CT Post Lung Biopsy Predict Patient Outcome?
The aim is to evaluate whether Minimum Dose CT (MnDCT) is useful in the management of patients post Lung Biopsy
Read the detailed description
Patients post Lung Biopsy have a chest X-ray (CXR) and a MnDCT post lung biopsy. Both studies are compared for the detection of a pneumothorax
- Conditions
- Lung Cancer
- Being tested
- CT
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of Pneumothorax
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJan 2004
- Study completionSep 2005
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.
- More trials run by University Health Network, TorontoThe 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Investigators
- Narinder Paul, FRCP C, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00188162
- Sponsor's protocol ID
- 03-0898
- Status last verified
- Sep 2005
- First submitted
- 12 Sep 2005
- Last updated
- 23 Apr 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Minimum Dose CT Post Lung Biopsy Predict Patient Outcome?
- ClinicalTrials.gov ID
- NCT00188162
- Acronym / sponsor ID
- 03-0898
- Conditions
- Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jan 2004
- Study completion
- Sep 2005 (actual)
- First posted
- 16 Sep 2005 (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.
The aim is to evaluate whether Minimum Dose CT (MnDCT) is useful in the management of patients post Lung Biopsy
Detailed description
Patients post Lung Biopsy have a chest X-ray (CXR) and a MnDCT post lung biopsy. Both studies are compared for the detection of a pneumothorax
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All Patients having a lung biopsy
Key exclusion criteria (1 listed)
- None
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 | Device | – |
Primary outcome
Detection of Pneumothorax
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 23 Apr 2007.
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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.
Narinder Paul, FRCP C principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CT in people with Lung Cancer, run by University Health Network, Toronto 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 1 inclusion and 1 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 23 Apr 2007. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Detection of Pneumothorax. 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 23 Apr 2007.