Positron Emission Tomography in Extrapulmonary Tuberculosis (TUBOGTEP)

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Extrapulmonary Tuberculosis; Lymph Node Tuberculosis; Bone Tuberculosis	Other: Positron Emission Tomography with 18F-Fluoro-deoxy-glucose	Not Applicable

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 Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	55 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Diagnostic
Official Title:	Evaluation of Positron Emission Tomography in Extrapulmonary Tuberculosis
Actual Study Start Date :	May 2012
Actual Primary Completion Date :	September 2016
Actual Study Completion Date :	March 2018

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Positron Emission Tomography; Positron Emission Tomography	Other: 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.; Other Name: PET with 18 FDG

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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 ]
   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 :

1. Change in SUVmax differences in the lesions according to their location in cured patients. [ Time Frame: 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
2. Variations ΣSUVmax and SUVmax in individual lesions in patients not cured. [ Time Frame: 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.
3. Frequency, type and consequences on the therapeutic management of lesions revealed by FDG-PET. [ Time Frame: 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.

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

France
BICHAT Claude Bernard
Paris, France, 75018

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:	Patrick Yeni, MD, PHD	Assistance Publique - Hôpitaux de Paris

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT01613196 History of Changes
Other Study ID Numbers:	AOM 11080; 2011-A01658-33 ( Other Identifier: IDRCB )
First Posted:	June 7, 2012
Last Update Posted:	March 29, 2018
Last Verified:	March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Extrapulmonary tuberculosis; FDG-TEP; cohorts

Additional relevant MeSH terms:

Tuberculosis; Tuberculosis, Lymph Node; Tuberculosis, Osteoarticular; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bone Diseases, Infectious	Infection; Bone Diseases; Musculoskeletal Diseases; Deoxyglucose; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Antiviral Agents; Anti-Infective Agents