Latent TuberculosisNCT02454738
Ultralow Dose Computed Tomography in High-risk Drug-resistant Tuberculosis Contacts
A study testing Ultralow dose chest CT scan in people with Latent Tuberculosis, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
To evaluate CT abnormalities in the lung parenchyma in close contacts at high risk for developing multidrug- or extensively drug-resistant Tb by using a follow-up ultralow dose CT scan. Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Latent Tuberculosis
- What is being tested?
- Ultralow dose chest CT scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2015to Jun 2016
- Phase
- Interventional
- 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 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals who had household contact with or who had worked in the same rooms as patients with smear-positive, culture-proven multidrug-or extensively drug-resistant pulmonary tuberculosis for longer than 8 hours per day
- Older than 20 years
Who cannot join
- Pregnant women
- Individuals with abnormality on chest x-ray suspected of active tuberculosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultralow Dose Computed Tomography in Close Contacts at High Risk for Developing Multidrug- or Extensively Drug-resistant Tuberculosis: A Pilot Study
To evaluate CT abnormalities in the lung parenchyma in close contacts at high risk for developing multidrug- or extensively drug-resistant Tb by using a follow-up ultralow dose CT scan.
Read the detailed description
Multidrug- or extensively resistant tuberculosis tuberculosis is a major public health threat worldwide and the global burden of drug-resistant tuberculosis is increasing. Drug-resistant tuberculosis is associated with long period and high costs for treatment, high rates of default, treatment failure and death.
Drug-resistant tuberculosis should be diagnosed rapidly so as to reduce potential transmission. In the United States, at least one-fifths cases of multidrug-resistant tuberculosis can be linked to transmission. Close contacts to drug-resistant tuberculosis are at high risk for being transmitted and developing drug-resistant tuberculosis. There are two options suggested for close contacts to drug-resistant tuberculosis: preventive therapy and close observation. But both strategies are lack of sufficient evidence.
Ultralow chest CT scan may be an alternative for early identification and risk stratification of developing active tuberculosis in close contacts to drug-resistant tuberculosis with minimal radiation exposure similar to that of chest x-ray.
- Conditions
- Latent Tuberculosis
- Being tested
- Ultralow dose chest CT scan
- Keywords
- pulmonary tuberculosis, chest, ultralow dose computed tomography
- Medical subject headings
- Latent Tuberculosis, Tuberculosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultralow dose chest CT scanRadiation
Ultralow-dose chest CT scan is performed using a 64-row multidetector CT system (Discovery CT750HD; GE Healthcare, Waukesha, WI) with 1.25-mm-thick axial slices at less than 1 mSv (volume computed tomography dose index: 0.39 milligray).
| Study group | Role | What they receive |
|---|---|---|
| Chest CT scan | Experimental | Two follow-up ultralow dose chest CT scans will be taken 3 months and 1 year after the initial ultralow dose chest CT scan in close contact at high risk for developing multidrug- or extensively drug-resistant tuberculosis. Receives: Radiation: Ultralow dose chest CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interval change of CT abnormalities potentially suggesting active tuberculosis in the lung parenchyma during the follow-up.
Measured: 3 months and 1 year after the initial CT scanning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Latent TuberculosisStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Mo Goo, Seoul National University Hospital
- Investigators
- Jin Mo Goo, M.D., Principal investigator, Department of Radiology, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02454738
- Sponsor's protocol ID
- SNUHchestradiology-001
- Status last verified
- Jun 2016
- First submitted
- 22 May 2015
- Last updated
- 7 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Lee SC, Yoon SH, Goo JM, Yim JJ, Kim CK. Submillisievert Computed Tomography of the Chest in Contact Investigation for Drug-Resistant Tuberculosis. J Korean Med Sci. 2017 Nov;32(11):1779-1783. doi: 10.3346/jkms.2017.32.11.1779.
PubMed 28960029
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultralow Dose Computed Tomography in Close Contacts at High Risk for Developing Multidrug- or Extensively Drug-resistant Tuberculosis: A Pilot Study
- ClinicalTrials.gov ID
- NCT02454738
- Acronym / sponsor ID
- SNUHchestradiology-001
- Conditions
- Latent Tuberculosis
- Keywords
- pulmonary tuberculosis, chest, ultralow dose computed tomography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 27 May 2015 (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.
To evaluate CT abnormalities in the lung parenchyma in close contacts at high risk for developing multidrug- or extensively drug-resistant Tb by using a follow-up ultralow dose CT scan.
Detailed description
Multidrug- or extensively resistant tuberculosis tuberculosis is a major public health threat worldwide and the global burden of drug-resistant tuberculosis is increasing. Drug-resistant tuberculosis is associated with long period and high costs for treatment, high rates of default, treatment failure and death.
Drug-resistant tuberculosis should be diagnosed rapidly so as to reduce potential transmission. In the United States, at least one-fifths cases of multidrug-resistant tuberculosis can be linked to transmission. Close contacts to drug-resistant tuberculosis are at high risk for being transmitted and developing drug-resistant tuberculosis. There are two options suggested for close contacts to drug-resistant tuberculosis: preventive therapy and close observation. But both strategies are lack of sufficient evidence.
Ultralow chest CT scan may be an alternative for early identification and risk stratification of developing active tuberculosis in close contacts to drug-resistant tuberculosis with minimal radiation exposure similar to that of chest x-ray.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chest CT scan | Experimental | Radiation: Ultralow dose chest CT scanTwo follow-up ultralow dose chest CT scans will be taken 3 months and 1 year after the initial ultralow dose chest CT scan in close contact at high risk for developing multidrug- or extensively drug-resistant tuberculosis. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Individuals who had household contact with or who had worked in the same rooms as patients with smear-positive, culture-proven multidrug-or extensively drug-resistant pulmonary tuberculosis for longer than 8 hours per day
- Older than 20 years
Key exclusion criteria (2 listed)
- Pregnant women
- Individuals with abnormality on chest x-ray suspected of active tuberculosis
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 |
|---|---|---|
| Ultralow dose chest CT scanUltralow-dose chest CT scan is performed using a 64-row multidetector CT system (Discovery CT750HD; GE Healthcare, Waukesha, WI) with 1.25-mm-thick axial slices at less than 1 mSv (volume computed tomography dose index: 0.39 milligray). | Radiation | Chest CT scan |
Primary outcome
Interval change of CT abnormalities potentially suggesting active tuberculosis in the lung parenchyma during the follow-up.
Time frame: 3 months and 1 year after the initial CT scanning
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 7 Jun 2016.
- Derived from this study: PubMed 28960029Lee SC, Yoon SH, Goo JM, Yim JJ, Kim CK. Submillisievert Computed Tomography of the Chest in Contact Investigation for Drug-Resistant Tuberculosis. J Korean Med Sci. 2017 Nov;32(11):1779-1783. doi: 10.3346/jkms.2017.32.11.1779.
- Individual participant dataSharing planned: Yes
Related trials for Latent Tuberculosis
RecruitingPhase 1/2
A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV
Tuberculosis
RecruitingObservational study
Training Protocol on the Natural History of Tuberculosis
Mycobacterium Infections, Tuberculosis, Multidrug-Resistant
RecruitingPhase 2/3
Bedaquiline Roll-out Evidence in Contacts and People Living With HIV to Prevent TB
Tuberculosis, Latent
RecruitingPhase 2
BPaLMZ for TB Meningitis
Tuberculous Meningitis, HIV
Recruiting
Screening With Portable X-rays for Rapid Recognition of TB
Tuberculosis (TB), Tuberculosis Infection, Latent
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.
Jin Mo Goo, M.D. principal investigator
Department of Radiology, Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultralow dose chest CT scan in people with Latent Tuberculosis, run by Seoul National University Hospital at 1 site in South Korea.
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 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 7 Jun 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 South Korea. 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?
Interval change of CT abnormalities potentially suggesting active tuberculosis in the lung parenchyma during the follow-up. (time frame: 3 months and 1 year after the initial CT scanning). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02454738, which also lists 1 linked publication.
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 7 Jun 2016.