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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-A01658-33 | Other Identifier | IDRCB |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Positron Emission Tomography | Experimental | Positron Emission Tomography |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Positron Emission Tomography with 18F-Fluoro-deoxy-glucose | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 to 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 to 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Yeni, MD, PHD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BICHAT Claude Bernard | Paris | 75018 | France |
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| ID | Term |
|---|---|
| D000092225 | Tuberculosis, Extrapulmonary |
| D014388 | Tuberculosis, Lymph Node |
| D014394 | Tuberculosis, Osteoarticular |
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| C062942 | 2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole |
| D019788 | Fluorodeoxyglucose F18 |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D003847 | Deoxyglucose |
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|
| 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. |
| 6 to 18 months |
| 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. | 6 to 18 months |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D001850 | Bone Diseases, Infectious |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D003837 | Deoxy Sugars |
| D002241 | Carbohydrates |