Ultralow Dose Computed Tomography in High-risk Drug-resistant Tuberculosis Contacts

NCT ID: NCT02454738

Last Updated: 2016-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2016-06-30

Brief Summary

To evaluate CT abnormalities in the lung parenchyma in close contacts at high risk for developing multidrug- or extensively drug-resistant Tb by using a follow-up ultralow dose CT scan.

Detailed Description

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.

Conditions

Latent Tuberculosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Ultralow dose chest CT scan

Intervention Type: RADIATION

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).

Interventions

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).

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Individuals who had household contact with or who had worked in the same rooms as patients with smear-positive, culture-proven multidrug-or extensively drug-resistant pulmonary tuberculosis for longer than 8 hours per day
• Older than 20 years

Exclusion Criteria

• Pregnant women
• Individuals with abnormality on chest x-ray suspected of active tuberculosis

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jin Mo Goo

Professor, Department of Radiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jin Mo Goo, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Radiology, Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, Jongno-gu, South Korea

Countries

South Korea

References

Lee SC, Yoon SH, Goo JM, Yim JJ, Kim CK. Submillisievert Computed Tomography of the Chest in Contact Investigation for Drug-Resistant Tuberculosis. J Korean Med Sci. 2017 Nov;32(11):1779-1783. doi: 10.3346/jkms.2017.32.11.1779.

Reference Type: DERIVED

PMID: 28960029 (View on PubMed)

Other Identifiers

SNUHchestradiology-001

Identifier Type: -

Identifier Source: org_study_id