Positron Emission Tomography in Extrapulmonary Tuberculosis

Not Applicable

Completed

• Conditions: Extrapulmonary Tuberculosis; Bone Tuberculosis; Lymph Node Tuberculosis
• Interventions: Other: Positron Emission Tomography with 18F-Fluoro-deoxy-glucose

• Registration Number: NCT01613196
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief 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

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-14
• Study First Submitted QC: 2012-06-04
• Study First Posted: 2012-06-07
• Primary Completion: 2016-09
• Status Verified: 2018-03
• Study Completion: 2018-03
• Last Update Submitted: 2018-03-27
• Last Update Posted: 2018-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Positron Emission Tomography	Positron Emission Tomography with 18F-Fluoro-deoxy-glucose	Positron Emission Tomography

Primary Outcome Measures

Name	Time	Method
ΣSUVmax variations between the beginning and end of treatment and during follow-up post-treatment, in patients considered cured	6 to 18 months	To measure FDG uptake and evolution, the ΣSUVmax will be used. SUV ("Standard Uptake Value") is defined as tissue concentration of FDG / administered FDG dose / patient weight. ΣSUVmax is the sum of the maximum SUV measured in every TB foci. ΣSUVmax variations between the beginning and the end of treatment, and 6 months later in cases of persistent uptake at the end of treatment will be studied in patients considered cured

Secondary Outcome Measures

Name	Time	Method
Change in SUVmax differences in the lesions according to their location in cured patients.	6 to 18 months	SUV variations between the beginning and the end of treatment, and 6 months later in cases of persistent uptake at the end of treatment will be studied in the lesions according to their location in cured patients
Variations ΣSUVmax and SUVmax in individual lesions in patients not cured.	6 to 18 months	ΣSUVmax variations between the beginning and the end of treatment, and 6 months later in cases of persistent uptake at the end of treatment will be studied in patients not cured.
Frequency, type and consequences on the therapeutic management of lesions revealed by FDG-PET.	6 to 18 months	Changes in composition or treatment duration will be identified and reported to the information provided by FDG-PET during the study.

Trial Locations

Locations (1)

BICHAT Claude Bernard; 🇫🇷 Paris, France