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

Tuberculosis, Pulmonary Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03220464
• Other study ID #: 1704-157-849
• Status: Recruiting
• Phase: N/A
• First received: June 25, 2017
• Last updated: July 18, 2017
• Start date: June 20, 2017
• Est. completion date: April 30, 2020

Study information

• Verified date: July 2017
• Source: Seoul National University Hospital
• Contact: Jae-Joon Yim, MD, PhD
• Phone: 82-2-2072-2059
• Email: yimjj[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 116
• Est. completion date: April 30, 2020
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Latent Tuberculosis
• Tuberculosis
• Tuberculosis, Pulmonary

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (8)

Fox GJ, Barry SE, Britton WJ, Marks GB. Contact investigation for tuberculosis: a systematic review and meta-analysis. Eur Respir J. 2013 Jan;41(1):140-56. doi: 10.1183/09031936.00070812. Epub 2012 Aug 30. Review. Erratum in: Eur Respir J. 2015 Aug;46(2): — View Citation

Fujikawa A, Fujii T, Mimura S, Takahashi R, Sakai M, Suzuki S, Kyoto Y, Uwabe Y, Maeda S, Mori T. Tuberculosis contact investigation using interferon-gamma release assay with chest x-ray and computed tomography. PLoS One. 2014 Jan 14;9(1):e85612. doi: 10. — View Citation

Lee SW, Jang YS, Park CM, Kang HY, Koh WJ, Yim JJ, Jeon K. The role of chest CT scanning in TB outbreak investigation. Chest. 2010 May;137(5):1057-64. doi: 10.1378/chest.09-1513. Epub 2009 Oct 31. — View Citation

Lew WJ, Jung YJ, Song JW, Jang YM, Kim HJ, Oh YM, Lee SD, Kim WS, Kim DS, Kim WD, Shim TS. Combined use of QuantiFERON-TB Gold assay and chest computed tomography in a tuberculosis outbreak. Int J Tuberc Lung Dis. 2009 May;13(5):633-9. — View Citation

Piccazzo R, Paparo F, Garlaschi G. Diagnostic accuracy of chest radiography for the diagnosis of tuberculosis (TB) and its role in the detection of latent TB infection: a systematic review. J Rheumatol Suppl. 2014 May;91:32-40. doi: 10.3899/jrheum.140100. — View Citation

Sloot R, Schim van der Loeff MF, Kouw PM, Borgdorff MW. Risk of tuberculosis after recent exposure. A 10-year follow-up study of contacts in Amsterdam. Am J Respir Crit Care Med. 2014 Nov 1;190(9):1044-52. doi: 10.1164/rccm.201406-1159OC. — View Citation

World Health Organization (World Health Organization). Guidelines on the management of latent tuberculosis infection. World Health Organization, 2015.

World Health Organization, and Stop TB Initiative (World Health Organization). Treatment of tuberculosis: guidelines. World Health Organization, 2010.

Outcome

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

External Links

•   Guidelines on the management of latent tuberculosis infection
•   Treatment of tuberculosis: guidelines