NCT01613196

Positron Emission Tomography in Extrapulmonary Tuberculosis

Evaluation of Positron Emission Tomography in Extrapulmonary Tuberculosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Tuberculosis (TB) remains a major public health problem. In extra-pulmonary forms, evidence of bacteriological cure is difficult to be obtained raising the need for other therapeutic assessment tools. 18F-Fluoro-deoxy-glucose (FDG) is a glucose analogue widely used in Positron Emission Tomography (PET). Its uptake is high in cancer cells and in inflammatory cells, especially in active TB foci. The hypothesis is a decrease in the uptake of FDG in the foci of TB during treatment permitting a non-invasive monitoring of therapeutic response. The main objective is to describe the evolution under treatment of the FDG uptake in PET imaging in TB foci in patients cured from lymph node and bone TB. Secondary objectives are to compare the decrease of FDG uptake according to type of location, to define the frequency of localizations revealed by FDG-PET and their impact on therapeutic management at the beginning and the end of treatment, and to describe the evolution of PET in patients not cured.

Detailed description

Longitudinal observational multicenter pilot study. 55 patients to be included Total duration of the study: 51 months. Inclusion period: 27 months Follow up period: 18 to 24 months Number of participating centers: 11 Average number of inclusion per month per center: 1-2

Conditions

• Extrapulmonary Tuberculosis
• Lymph Node Tuberculosis
• Bone Tuberculosis

Interventions

Type	Name	Description
OTHER	Positron Emission Tomography with 18F-Fluoro-deoxy-glucose	2 or 3 FDG-PET scans will be performed in all patients : at inclusion\*, end of treatment and 6 months after completion of treatment in cases of persistent uptake \*except if already done in the last 15 days.

Timeline

• Start date: 2012-05-01
• Primary completion: 2016-09-01
• Completion: 2018-03-01
• First posted: 2012-06-07
• Last updated: 2018-03-29

Locations

1 site across 1 country: France