Ultralow Dose Computed Tomography in High-risk Drug-resistant Tuberculosis Contacts
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|ClinicalTrials.gov Identifier: NCT02454738|
Recruitment Status : Completed
First Posted : May 27, 2015
Last Update Posted : June 7, 2016
|Condition or disease||Intervention/treatment||Phase|
|Latent Tuberculosis||Radiation: Ultralow dose chest CT scan||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Ultralow Dose Computed Tomography in Close Contacts at High Risk for Developing Multidrug- or Extensively Drug-resistant Tuberculosis: A Pilot Study|
|Study Start Date :||June 2015|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||June 2016|
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
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).
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02454738
|Korea, Republic of|
|Seoul National University Hospital|
|Seoul, Jongno-gu, Korea, Republic of|
|Principal Investigator:||Jin Mo Goo, M.D.||Department of Radiology, Seoul National University Hospital|