Ultralow Dose Computed Tomography in High-risk Drug-resistant Tuberculosis Contacts
1 other identifier
interventional
6
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2015
CompletedFirst Posted
Study publicly available on registry
May 27, 2015
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedJune 7, 2016
June 1, 2016
1 year
May 22, 2015
June 6, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Interval change of CT abnormalities potentially suggesting active tuberculosis in the lung parenchyma during the follow-up.
3 months and 1 year after the initial CT scanning
Study Arms (1)
Chest CT scan
EXPERIMENTALTwo 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.
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pregnant women
- Individuals with abnormality on chest x-ray suspected of active tuberculosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, Jongno-gu, South Korea
Related Publications (1)
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.
PMID: 28960029DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jin Mo Goo, M.D.
Department of Radiology, Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Department of Radiology
Study Record Dates
First Submitted
May 22, 2015
First Posted
May 27, 2015
Study Start
June 1, 2015
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
June 7, 2016
Record last verified: 2016-06
Data Sharing
- IPD Sharing
- Will share