Early Diagnosis of Active Tuberculosis Using Ultra Low-dose Chest CT

Not Applicable

• Conditions: Latent Tuberculosis; Tuberculosis, Pulmonary
• Interventions: Radiation: Ultra low dose chest computed tomography (ULDCT); Radiation: Chest X-ray; Diagnostic Test: Interferon-gamma Release Assay (IGRA)

• Registration Number: NCT03220464
• Lead Sponsor: Seoul National University Hospital

Brief Summary

The aim of this study is to evaluate ultra low dose chest computed tomography (ULDCT) for early diagnosis of active tuberculosis in cohort of close contacts of active pulmonary tuberculosis for 1 year follow up

Detailed Description

The early diagnosis of active tuberculosis in close contacts have not yet been established. To evaluate the early detection of active pulmonary tuberculosis using ULDCT, the investigators will establish the observational cohort of close contacts living in the same space with active pulmonary tuberculosis. Participants will visit our center at enrollment, after 3 months, and 12 months and will be received ULDCT, chest X-ray and Interferon-gamma assays at each visit. One chest radiologist will interpret findings of ULDCT and chest X-ray.

Patients diagnosed with active tuberculosis will be excluded from the study and treated based on World Health Organization guidelines.

Study Timeline

• Study Start: 2017-06-20
• Study First Submitted: 2017-06-25
• Status Verified: 2017-07
• Study First Submitted QC: 2017-07-15
• Study First Posted: 2017-07-18
• Last Update Submitted: 2017-07-18
• Last Update Posted: 2017-07-21
• Primary Completion: 2019-04-30
• Study Completion: 2020-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

• Close contacts of active pulmonary tuberculosis
• Family members of active TB patient who has lived together for more than one month, or work colleagues of active TB patient who has been working in the same office for more than 8 months
• Participants who received explanation of the research plan, understands and writes agreement.

Exclusion Criteria

• Vulnerable subjects with mental retardation or severe mental illness
• Patients who could not receive chest CT
• Pregnancy
• Close contacts who diagnosed active pulmonary tuberculosis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Close contacts of active pulmonary tuberculosis patients	Chest X-ray	One arm study of conducting ULDCT, chest x-ray, and IGRA
Close contacts of active pulmonary tuberculosis patients	Ultra low dose chest computed tomography (ULDCT)	One arm study of conducting ULDCT, chest x-ray, and IGRA
Close contacts of active pulmonary tuberculosis patients	Interferon-gamma Release Assay (IGRA)	One arm study of conducting ULDCT, chest x-ray, and IGRA

Primary Outcome Measures

Name	Time	Method
Incidence of active pulmonary tuberculosis	For a year	Active pulmonary tuberculosis defined by WHO guidelines for treatment of drug-susceptible tuberculosis and patient care (2017 update)

Secondary Outcome Measures

Name	Time	Method
Prevalence of active pulmonary tuberculosis at enrollment	Baseline	Active pulmonary tuberculosis defined by WHO guidelines for treatment of drug-susceptible tuberculosis and patient care (2017 update)
Prevalence of latent tuberculosis at enrollment	Baseline	Latent tuberculosis defined by guidelines on the management of latent tuberculosis infection
Change of ultra low dose chest CT findings in latent tuberculosis patients	Baseline, 3-month follow-up, and 12-month follow-up	Serial comparison analysis of CT findings in latent tuberculosis patients who diagnosed latent tuberculosis based on IFN-gamma assay

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of