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

Seoul National University logo

Seoul National University

Status

Unknown

Conditions

Tuberculosis, Pulmonary
Latent Tuberculosis

Treatments

Radiation: Ultra low dose chest computed tomography (ULDCT)
Radiation: Chest X-ray
Diagnostic Test: Interferon-gamma Release Assay (IGRA)

Study type

Interventional

Funder types

Other

Identifiers

NCT03220464
1704-157-849

Details and patient eligibility

About

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

Full 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.

Enrollment

116 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Screening

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

116 participants in 1 patient group

Close contacts of active pulmonary tuberculosis patients
Experimental group
Description:
One arm study of conducting ULDCT, chest x-ray, and IGRA
Treatment:
Radiation: Ultra low dose chest computed tomography (ULDCT)
Diagnostic Test: Interferon-gamma Release Assay (IGRA)
Radiation: Chest X-ray

Trial contacts and locations

1

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Central trial contact

Jae-Joon Yim, MD, PhD

Data sourced from clinicaltrials.gov

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