Positron Emission Tomography in Extrapulmonary Tuberculosis (TUBOGTEP)
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|ClinicalTrials.gov Identifier: NCT01613196|
Recruitment Status : Completed
First Posted : June 7, 2012
Last Update Posted : June 15, 2017
|Condition or disease||Intervention/treatment|
|Extrapulmonary Tuberculosis Lymph Node Tuberculosis Bone Tuberculosis||Other: Positron Emission Tomography with 18F-Fluoro-deoxy-glucose|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Positron Emission Tomography in Extrapulmonary Tuberculosis|
|Actual Study Start Date :||May 2012|
|Primary Completion Date :||September 2016|
|Study Completion Date :||December 2016|
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
- 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 ]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
- Change in SUVmax differences in the lesions according to their location in cured patients. [ Time Frame: 6 to 18 months ]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 ]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 ]Changes in composition or treatment duration will be identified and reported to the information provided by FDG-PET during the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01613196
|BICHAT Claude Bernard|
|Paris, France, 75018|
|Principal Investigator:||Patrick Yeni, MD, PHD||Assistance Publique - Hôpitaux de Paris|