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Positron Emission Tomography in Extrapulmonary Tuberculosis (TUBOGTEP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01613196
First received: May 14, 2012
Last updated: December 12, 2016
Last verified: December 2016
  Purpose
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 Intervention
Extrapulmonary Tuberculosis
Lymph Node Tuberculosis
Bone Tuberculosis
Other: Positron Emission Tomography with 18F-Fluoro-deoxy-glucose

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation of Positron Emission Tomography in Extrapulmonary Tuberculosis

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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:
  • 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

  • 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.

  • 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.


Enrollment: 55
Study Start Date: May 2012
Study Completion Date: December 2016
Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01613196

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

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 )
Study First Received: May 14, 2012
Last Updated: December 12, 2016
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Extrapulmonary tuberculosis
FDG-TEP
cohorts

Additional relevant MeSH terms:
Tuberculosis
Tuberculosis, Osteoarticular
Tuberculosis, Lymph Node
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

ClinicalTrials.gov processed this record on April 25, 2017