Overview

This trial is active, not recruiting.

Conditions extrapulmonary tuberculosis, lymph node tuberculosis, bone tuberculosis
Treatment positron emission tomography with 18f-fluoro-deoxy-glucose
Sponsor Assistance Publique - Hôpitaux de Paris
Start date May 2012
End date August 2016
Trial size 55 participants
Trial identifier NCT01613196, 2011-A01658-33, AOM 11080

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
Positron Emission Tomography
positron emission tomography with 18f-fluoro-deoxy-glucose PET with 18 FDG
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.

Primary Outcomes

Measure
ΣSUVmax variations between the beginning and end of treatment and during follow-up post-treatment, in patients considered cured
time frame: 6 to 18 months

Secondary Outcomes

Measure
Change in SUVmax differences in the lesions according to their location in cured patients.
time frame: 6 to 18 months
Variations ΣSUVmax and SUVmax in individual lesions in patients not cured.
time frame: 6 to 18 months
Frequency, type and consequences on the therapeutic management of lesions revealed by FDG-PET.
time frame: 6 to 18 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Evaluation of Positron Emission Tomography in Extrapulmonary Tuberculosis
Principal investigator Patrick Yeni, MD, PHD
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
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris.