Positron Emission Tomography in Extrapulmonary Tuberculosis (TUBOGTEP)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Bone Tuberculosis; Lymph Node Tuberculosis; Extrapulmonary Tuberculosis

Treatments: Other: Positron Emission Tomography with 18F-Fluoro-deoxy-glucose

Study type: Interventional

Funder types: Other

Identifiers

NCT01613196

2011-A01658-33 (Other Identifier)

AOM 11080

Details and patient eligibility

About

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.

Full 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

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults
• Affiliated to a social security system or "AME"
• Patient informed of the objectives and constraints of the study and giving informed consent
• Patient can keep lying valid at least 30 minutes
• Patient not HIV infected or, if infected, with CD4 counts> 200/mm3 for at least 3 months

Exclusion criteria

• Suspicion of other concurrent infection
• Severe immunosuppression in case of HIV infection
• Inflammatory disease
• Pregnant or nursing women
• Radiation therapy
• Uncontrolled diabetes
• Prolonged corticosteroid therapy (> 20mg/day)
• Patient unable to sustain injected CT scan and MRI

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 1 patient group

Positron Emission Tomography

Experimental group

Description:

Positron Emission Tomography

Treatment:

Other: Positron Emission Tomography with 18F-Fluoro-deoxy-glucose