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
: March 29, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Extrapulmonary Tuberculosis Lymph Node Tuberculosis Bone Tuberculosis | Other: Positron Emission Tomography with 18F-Fluoro-deoxy-glucose | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 55 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Evaluation of Positron Emission Tomography in Extrapulmonary Tuberculosis |
Actual Study Start Date : | May 2012 |
Actual Primary Completion Date : | September 2016 |
Actual Study Completion Date : | March 2018 |

Arm | Intervention/treatment |
---|---|
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
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- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adults
- Affiliated to a social security system or "AME"
- 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

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
France | |
BICHAT Claude Bernard | |
Paris, France, 75018 |
Principal Investigator: | Patrick Yeni, MD, PHD | Assistance Publique - Hôpitaux de Paris |
Responsible Party: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT01613196 History of Changes |
Other Study ID Numbers: |
AOM 11080 2011-A01658-33 ( Other Identifier: IDRCB ) |
First Posted: | June 7, 2012 Key Record Dates |
Last Update Posted: | March 29, 2018 |
Last Verified: | March 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Extrapulmonary tuberculosis FDG-TEP cohorts |
Additional relevant MeSH terms:
Tuberculosis Tuberculosis, Lymph Node Tuberculosis, Osteoarticular Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Bone Diseases, Infectious |
Infection Bone Diseases Musculoskeletal Diseases Deoxyglucose Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents |