Positron Emission Tomography in Extrapulmonary Tuberculosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2018-03-31

Brief Summary

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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.

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Detailed Description

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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

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Extrapulmonary Tuberculosis Lymph Node Tuberculosis Bone Tuberculosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Positron Emission Tomography

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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PET with 18 FDG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No