Positron Emission Tomography in Extrapulmonary Tuberculosis - Full Text View

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

Drug Information available for: Fludeoxyglucose F 18

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 2015
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 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

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 40 25 64 15 ext 33	laure.sarda@bch.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:	June 8, 2012
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Extrapulmonary tuberculosis
FDG-TEP
cohorts

Additional relevant MeSH terms:

Tuberculosis, Lymph Node
Tuberculosis
Tuberculosis, Osteoarticular
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lymphadenitis
Lymphatic Diseases
Bone Diseases, Infectious

Infection
Bone Diseases
Musculoskeletal Diseases
Deoxyglucose
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013

Positron Emission Tomography in Extrapulmonary Tuberculosis (TUBOGTEP)