Ultralow Dose Computed Tomography in High-risk Drug-resistant Tuberculosis Contacts
Primary Purpose
Latent Tuberculosis
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ultralow dose chest CT scan
Sponsored by
About this trial
This is an interventional diagnostic trial for Latent Tuberculosis focused on measuring pulmonary tuberculosis, chest, ultralow dose computed tomography
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Pregnant women
- Individuals with abnormality on chest x-ray suspected of active tuberculosis
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Chest CT scan
Arm Description
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.
Outcomes
Primary Outcome Measures
Interval change of CT abnormalities potentially suggesting active tuberculosis in the lung parenchyma during the follow-up.
Secondary Outcome Measures
Full Information
NCT ID
NCT02454738
First Posted
May 22, 2015
Last Updated
June 6, 2016
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02454738
Brief Title
Ultralow Dose Computed Tomography in High-risk Drug-resistant Tuberculosis Contacts
Official Title
Ultralow Dose Computed Tomography in Close Contacts at High Risk for Developing Multidrug- or Extensively Drug-resistant Tuberculosis: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Latent Tuberculosis
Keywords
pulmonary tuberculosis, chest, ultralow dose computed tomography
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Chest CT scan
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Ultralow dose chest CT scan
Intervention Description
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).
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Pregnant women
Individuals with abnormality on chest x-ray suspected of active tuberculosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin Mo Goo, M.D.
Organizational Affiliation
Department of Radiology, Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Jongno-gu
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
28960029
Citation
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.
Results Reference
derived
Learn more about this trial
Ultralow Dose Computed Tomography in High-risk Drug-resistant Tuberculosis Contacts
We'll reach out to this number within 24 hrs