Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

Positron Emission Tomography in Extrapulmonary Tuberculosis (TUBOGTEP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01613196
First received: May 14, 2012
Last updated: September 15, 2014
Last verified: January 2013
History of Changes
  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:

MedlinePlus related topics: Tuberculosis
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Changes in composition or treatment duration will be identified and reported to the information provided by FDG-PET during the study.
Estimated Enrollment: 55
Study Start Date: May 2012
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2015 (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: 36 months. Inclusion period: 12 months Follow up period: 18 to 24 months Number of participating centers: 8 Average number of inclusion per month per center: 1-2

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults
  • Affiliated to a social security system
  • 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

Contacts
Contact: Patrick YENI, MD, PHD 01 40 25 78 06 ext 33 patrick.yeni@bch.aphp.fr
Contact: Laure SARDA MANTEL, MD, PHD 01 49 95 82 68 ext 33 laure.sarda-mantel@lrb.aphp.fr

Locations
France
BICHAT Claude Bernard Recruiting
Paris, France, 75018
Contact: Christophe RIOUX, MD    01 40 25 78 83 ext 33    christophe.rioux@bch.aphp.fr   
Contact: Laure SARDA, MD, PHD    01 40 25 64 15 ext 33    laure.sarda@bch.aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Patrick Yeni, MD, PHD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01613196     History of Changes
Other Study ID Numbers: AOM 11080, 2011-A01658-33
Study First Received: May 14, 2012
Last Updated: September 15, 2014
Health Authority: France: Ministry of Health

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

Additional relevant MeSH terms:
Tuberculosis
Tuberculosis, Lymph Node
Actinomycetales Infections
Bacterial Infections
 Gram-Positive Bacterial Infections
Lymphadenitis
Lymphatic Diseases
Mycobacterium Infections

ClinicalTrials.gov processed this record on March 03, 2015