Clinical trial NCT01613196: Positron Emission Tomography in Extrapulmonary Tuberculosis
Official title: Evaluation of Positron Emission Tomography in Extrapulmonary Tuberculosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Extrapulmonary Tuberculosis
Lymph Node Tuberculosis
Bone Tuberculosis
Keywords: Extrapulmonary tuberculosis
FDG-TEP
cohorts
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2012-06-07
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

Eligibility criteria: 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

Primary outcomes:
measure: ΣSUVmax variations between the beginning and end of treatment and during follow-up post-treatment, in patients considered cured
timeFrame: 6 to 18 months
Secondary outcomes:
measure: Change in SUVmax differences in the lesions according to their location in cured patients.
timeFrame: 6 to 18 months
measure: Variations ΣSUVmax and SUVmax in individual lesions in patients not cured.
timeFrame: 6 to 18 months
measure: Frequency, type and consequences on the therapeutic management of lesions revealed by FDG-PET.
timeFrame: 6 to 18 months
Other outcomes:
Locations:
city: Paris
country: France
facility: BICHAT Claude Bernard
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Patrick Yeni, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References: