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CompletedNCT02454738Updated Jun 7, 2016

Ultralow Dose Computed Tomography in High-risk Drug-resistant Tuberculosis Contacts

An interventional study of Ultralow dose chest CT scan in Latent Tuberculosis, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 21 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-06-07.

Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
21 Years to 80 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Latent Tuberculosis

Keywords

  • pulmonary tuberculosis
  • chest
  • ultralow dose computed tomography
03

In context

Tuberculosis

1,417 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.

This study's enrollment of 6 is below the median of 150 across 952 interventional studies indexed under Tuberculosis.

Browse Tuberculosis studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Pregnant women
  • Individuals with abnormality on chest x-ray suspected of active tuberculosis
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    Chest CT scan

    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.

    Radiation: Ultralow dose chest CT scan

Interventions

  • RadiationUltralow dose chest CT scan

    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).

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 site
  • Seoul National University Hospital
    Seoul, Jongno-gu, Korea, Republic of
08

References and documents

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 ↗

Individual participant data

Plan to share: Yes

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 7, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02454738
Lead sponsor
Seoul National University Hospital
Responsible party
Jin Mo Goo (Professor, Department of Radiology, Seoul National University Hospital) — Principal investigator
First posted
May 27, 2015
Start date
Jun 2015
Primary completion
Jun 2016
Completion
Jun 2016
Last update
Jun 7, 2016

Study contacts

Jin Mo Goo, M.D.
principal investigator · Department of Radiology, Seoul National University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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