NCT03220464

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

Early Diagnosis of Active Tuberculosis Using Ultra Low-dose Chest CT to Predict Progression to Active Tuberculosis Among Contacts

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 116 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Tuberculosis, Pulmonary
• Latent Tuberculosis

Interventions

Type	Name	Description
RADIATION	Ultra low dose chest computed tomography (ULDCT)	Participants in the study will receive ULDCT at enrollment, after 3-month visit, and after 12-month visit.
RADIATION	Chest X-ray	Participants in the study will receive chest x-ray at enrollment, after 3-month visit, and after 12-month visit.
DIAGNOSTIC_TEST	Interferon-gamma Release Assay (IGRA)	Participants in the study will receive IGRA test at enrollment, after 3-month visit, and after 12-month visit. About 11mL of blood will be drawn from the participants for test of T-SPOT®.TB test and QuantiFERON test.

Timeline

• Start date: 2017-06-20
• Primary completion: 2019-04-30
• Completion: 2020-04-30
• First posted: 2017-07-18
• Last updated: 2017-07-21

Locations

1 site across 1 country: South Korea