NCT01613196

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

May 14, 2012

Completed
24 days until next milestone

First Posted

Study publicly available on registry

June 7, 2012

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

March 29, 2018

Status Verified

March 1, 2018

Enrollment Period

4.3 years

First QC Date

May 14, 2012

Last Update Submit

March 27, 2018

Conditions

Extrapulmonary TuberculosisLymph Node TuberculosisBone Tuberculosis

Keywords

Extrapulmonary tuberculosisFDG-TEPcohorts

Outcome Measures

Primary Outcomes (1)

  • ΣSUVmax 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 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

    6 to 18 months

Secondary Outcomes (3)

  • Change in SUVmax differences in the lesions according to their location in cured patients.

    6 to 18 months

  • Variations ΣSUVmax and SUVmax in individual lesions in patients not cured.

    6 to 18 months

  • Frequency, type and consequences on the therapeutic management of lesions revealed by FDG-PET.

    6 to 18 months

Study Arms (1)

Positron Emission Tomography

EXPERIMENTAL

Positron Emission Tomography

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

Interventions

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

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.

Also known as: PET with 18 FDG
Positron Emission Tomography

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BICHAT Claude Bernard

Paris, 75018, France

Location

MeSH Terms

Conditions

Tuberculosis, ExtrapulmonaryTuberculosis, Lymph NodeTuberculosis, Osteoarticular

Interventions

Magnetic Resonance Spectroscopy2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazoleFluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

TuberculosisMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsBone Diseases, InfectiousBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative TechniquesDeoxyglucoseDeoxy SugarsCarbohydrates

Study Officials

  • Patrick Yeni, MD, PHD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2012

First Posted

June 7, 2012

Study Start

May 1, 2012

Primary Completion

September 1, 2016

Study Completion

March 1, 2018

Last Updated

March 29, 2018

Record last verified: 2018-03

Locations

FR(1)