TuberculosisNCT01616264
Reproducibility of Computed Tomography
An observational study of Tuberculosis and Pleural Effusion, run by Universidade Federal do Rio de Janeiro.
Trial summary
Thus, the aim of this study was to evaluate the reproducibility of the Computed Tomograph scan three-dimensional reconstruction method for the measurement of the TB pleural effusion volume in clinically stable patients. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Tuberculosis, Pleural Effusion
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to Dec 2009
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients age 18 years or older with a confirmed diagnosis of pleural TB effusion
Who may be able to join
- Patients age 18 years with a confirmed diagnosis of pleural TB effusion .
- Signed out an informed consent term
Who cannot join
- Patients with human immunodeficiency virus (HIV).
About this study
Official title: Evaluation of the Reproducibility of Computed Tomography for the Measurement of Tuberculosis Pleural Effusion
Thus, the aim of this study was to evaluate the reproducibility of the Computed Tomograph scan three-dimensional reconstruction method for the measurement of the TB pleural effusion volume in clinically stable patients.
Read the detailed description
Speed, accuracy, and precision in the quantification of pleural effusion are of critical importance as it determines whether or not thoracocentesis should be carried out and which technique should be employed for such a procedure. This study evaluates the precision of thoracic computed tomography with three-dimensional (3D) rebuilding in determining the volume of tuberculosis pleural effusion.Twenty patients with pleural effusion were screened and invited to take part in the study. Each patient underwent two computed tomography scans, before and after one month of treatment for tuberculosis, a total of 40 exams. These were evaluated by two expert radiologists. In conclusion, the quantification of the pleural effusion volume by using thoracic CT with volumetric three-dimensional reconstruction is a highly reproducible method.
- Conditions
- Tuberculosis, Pleural Effusion
- Keywords
- Tuberculosis, Pleural Effusion, Computed Tomography
- Medical subject headings
- Tuberculosis, Pleural Effusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2012 (estimated)
- Study startJan 2006
- Primary completionOct 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies 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
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juliana Flávia de Oliveira, Universidade Federal do Rio de Janeiro
- Investigators
- Juliana F Oliveira, Phd, Principal investigator, Universidade Federal do Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01616264
- Sponsor's protocol ID
- JUL 200456
- Status last verified
- Jun 2012
- First submitted
- 7 Jun 2012
- Last updated
- 11 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Reproducibility of Computed Tomography for the Measurement of Tuberculosis Pleural Effusion
- ClinicalTrials.gov ID
- NCT01616264
- Acronym / sponsor ID
- JUL 200456
- Conditions
- Tuberculosis, Pleural Effusion
- Keywords
- Tuberculosis, Pleural Effusion, Computed Tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Oct 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 11 Jun 2012 (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.
Thus, the aim of this study was to evaluate the reproducibility of the Computed Tomograph scan three-dimensional reconstruction method for the measurement of the TB pleural effusion volume in clinically stable patients.
Detailed description
Speed, accuracy, and precision in the quantification of pleural effusion are of critical importance as it determines whether or not thoracocentesis should be carried out and which technique should be employed for such a procedure. This study evaluates the precision of thoracic computed tomography with three-dimensional (3D) rebuilding in determining the volume of tuberculosis pleural effusion.Twenty patients with pleural effusion were screened and invited to take part in the study. Each patient underwent two computed tomography scans, before and after one month of treatment for tuberculosis, a total of 40 exams. These were evaluated by two expert radiologists. In conclusion, the quantification of the pleural effusion volume by using thoracic CT with volumetric three-dimensional reconstruction is a highly reproducible method.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients age 18 years or older with a confirmed diagnosis of pleural TB effusion
Key inclusion criteria (2 listed)
- Patients age 18 years with a confirmed diagnosis of pleural TB effusion .
- Signed out an informed consent term
Key exclusion criteria (1 listed)
- Patients with human immunodeficiency virus (HIV).
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
Not reported in the source record.
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 11 Jun 2012.
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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.
Juliana F Oliveira, Phd principal investigator
Universidade Federal do Rio de Janeiro
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis and Pleural Effusion, run by Universidade Federal do Rio de Janeiro.
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 2 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 11 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
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.
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 11 Jun 2012.