search
Back to results

Positron Emission Tomography in Extrapulmonary Tuberculosis (TUBOGTEP)

Primary Purpose

Extrapulmonary Tuberculosis, Lymph Node Tuberculosis, Bone Tuberculosis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Positron Emission Tomography with 18F-Fluoro-deoxy-glucose
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Extrapulmonary Tuberculosis focused on measuring Extrapulmonary tuberculosis, FDG-TEP, cohorts

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • BICHAT Claude Bernard

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Positron Emission Tomography

Arm Description

Positron Emission Tomography

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Variations ΣSUVmax and SUVmax in individual lesions in patients not cured.
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.
Changes in composition or treatment duration will be identified and reported to the information provided by FDG-PET during the study.

Full Information

First Posted
May 14, 2012
Last Updated
March 27, 2018
Sponsor
Assistance Publique - Hôpitaux de Paris
search

1. Study Identification

Unique Protocol Identification Number
NCT01613196
Brief Title
Positron Emission Tomography in Extrapulmonary Tuberculosis
Acronym
TUBOGTEP
Official Title
Evaluation of Positron Emission Tomography in Extrapulmonary Tuberculosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
May 2012 (Actual)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extrapulmonary Tuberculosis, Lymph Node Tuberculosis, Bone Tuberculosis
Keywords
Extrapulmonary tuberculosis, FDG-TEP, cohorts

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Positron Emission Tomography
Arm Type
Experimental
Arm Description
Positron Emission Tomography
Intervention Type
Other
Intervention Name(s)
Positron Emission Tomography with 18F-Fluoro-deoxy-glucose
Other Intervention Name(s)
PET with 18 FDG
Intervention Description
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.
Primary Outcome Measure Information:
Title
ΣSUVmax variations between the beginning and end of treatment and during follow-up post-treatment, in patients considered cured
Description
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
Time Frame
6 to 18 months
Secondary Outcome Measure Information:
Title
Change in SUVmax differences in the lesions according to their location in cured patients.
Description
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
Time Frame
6 to 18 months
Title
Variations ΣSUVmax and SUVmax in individual lesions in patients not cured.
Description
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.
Time Frame
6 to 18 months
Title
Frequency, type and consequences on the therapeutic management of lesions revealed by FDG-PET.
Description
Changes in composition or treatment duration will be identified and reported to the information provided by FDG-PET during the study.
Time Frame
6 to 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Yeni, MD, PHD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
BICHAT Claude Bernard
City
Paris
ZIP/Postal Code
75018
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Positron Emission Tomography in Extrapulmonary Tuberculosis

We'll reach out to this number within 24 hrs