Skip to main content
OpenTrials
Completed

NCT Number: NCT01613196

Positron Emission Tomography in Extrapulmonary Tuberculosis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Extrapulmonary Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Bone Diseases Bone Diseases, Infectious Bone Tuberculosis Gram-Positive Bacterial Infections Infections Lymph Node Tuberculosis Musculoskeletal Diseases Mycobacterium Infections Tuberculosis Tuberculosis, Extrapulmonary Tuberculosis, Lymph Node Tuberculosis, Osteoarticular

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BICHAT Claude Bernard

Paris, 75018, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Other names: PET with 18 FDG

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Evaluation of Positron Emission Tomography in Extrapulmonary Tuberculosis

Acronym: TUBOGTEP

Important dates

Study start
2012
Primary completion
2016
Study completion
2018
First posted
Jun 7, 2012
Registry last updated
Mar 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.