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Evaluation of Positron Emission Tomography in Extrapulmonary Tuberculosis


N/A
18 Years
N/A
Open (Enrolling)
Both
Extrapulmonary Tuberculosis, Lymph Node Tuberculosis, Bone Tuberculosis

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Trial Information

Evaluation of Positron Emission Tomography in Extrapulmonary Tuberculosis


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


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

ΣSUVmax variations between the beginning and end of treatment and during follow-up post-treatment, in patients considered cured

Outcome 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

Outcome Time Frame:

6 to 18 months

Safety Issue:

No

Principal Investigator

Patrick Yeni, MD, PHD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Assistance Publique - Hôpitaux de Paris

Authority:

France: Ministry of Health

Study ID:

AOM 11080

NCT ID:

NCT01613196

Start Date:

May 2012

Completion Date:

May 2015

Related Keywords:

  • Extrapulmonary Tuberculosis
  • Lymph Node Tuberculosis
  • Bone Tuberculosis
  • Extrapulmonary tuberculosis
  • FDG-TEP
  • cohorts
  • Tuberculosis
  • Tuberculosis, Lymph Node
  • Tuberculosis, Osteoarticular

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