Positron Emission Tomography in Extrapulmonary Tuberculosis

Extrapulmonary Tuberculosis Clinical Trial

— TUBOGTEP  

Official title:

Evaluation of Positron Emission Tomography in Extrapulmonary Tuberculosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01613196
• Other study ID #: AOM 11080
• Secondary ID: 2011-A01658-33
• Status: Completed
• Phase: N/A
• First received: May 14, 2012
• Last updated: March 27, 2018
• Start date: May 2012
• Est. completion date: March 2018

Study information

• Verified date: March 2018
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: March 2018
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Tuberculosis
• Extrapulmonary Tuberculosis
• Lymph Node Tuberculosis
• Tuberculosis

Intervention

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.

Locations

Country	Name	City	State
France	BICHAT Claude Bernard	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SSUVmax variations between the beginning and end of treatment and during follow-up post-treatment, in patients considered cured	To measure FDG uptake and evolution, the SSUVmax will be used. SUV ("Standard Uptake Value") is defined as tissue concentration of FDG / administered FDG dose / patient weight. SSUVmax is the sum of the maximum SUV measured in every TB foci. SSUVmax 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	6 to 18 months
Secondary	Change in SUVmax differences in the lesions according to their location in cured patients.	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	6 to 18 months
Secondary	Variations SSUVmax and SUVmax in individual lesions in patients not cured.	SSUVmax 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.	6 to 18 months
Secondary	Frequency, type and consequences on the therapeutic management of lesions revealed by FDG-PET.	Changes in composition or treatment duration will be identified and reported to the information provided by FDG-PET during the study.	6 to 18 months