Extrapulmonary TuberculosisTUBOGTEPNCT01613196
Positron Emission Tomography in Extrapulmonary Tuberculosis
A study testing Positron Emission Tomography with 18F-Fluoro-deoxy-glucose in people with Extrapulmonary Tuberculosis and Lymph Node Tuberculosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extrapulmonary Tuberculosis, Lymph Node Tuberculosis, Bone Tuberculosis
- What is being tested?
- Positron Emission Tomography with 18F-Fluoro-deoxy-glucose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteFrance
- Study dates
- May 2012to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Positron Emission Tomography in Extrapulmonary Tuberculosis
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.
Read the detailed description
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
- Being tested
- Positron Emission Tomography with 18F-Fluoro-deoxy-glucose
- Keywords
- Extrapulmonary tuberculosis, FDG-TEP, cohorts
- Medical subject headings
- Tuberculosis, Extrapulmonary, Tuberculosis, Lymph Node, Tuberculosis, Osteoarticular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positron Emission Tomography with 18F-Fluoro-deoxy-glucoseOther
Also called PET with 18 FDG
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.
| Study group | Role | What they receive |
|---|---|---|
| Positron Emission Tomography | Experimental | Positron Emission Tomography Receives: Other: Positron Emission Tomography with 18F-Fluoro-deoxy-glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 to 18 months
Secondary outcomes (3)
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
Measured: 6 to 18 months
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.
Measured: 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.
Measured: 6 to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2012 (estimated)
- Study startMay 2012
- Primary completionSep 2016
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extrapulmonary TuberculosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Yeni, MD, PHD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01613196
- Sponsor's protocol ID
- AOM 11080
- Other IDs
- 2011-A01658-33
- Acronym
- TUBOGTEP
- Status last verified
- Mar 2018
- First submitted
- 14 May 2012
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Positron Emission Tomography in Extrapulmonary Tuberculosis
- ClinicalTrials.gov ID
- NCT01613196
- Acronym / sponsor ID
- TUBOGTEP / AOM 11080
- Keywords
- Extrapulmonary tuberculosis, FDG-TEP, cohorts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- May 2012 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 7 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Positron Emission Tomography | Experimental | Other: Positron Emission Tomography with 18F-Fluoro-deoxy-glucosePositron Emission Tomography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- Suspicion of other concurrent infection
- Severe immunosuppression in case of HIV infection
- Inflammatory disease
- Pregnant or nursing women
- Radiation therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positron Emission Tomography with 18F-Fluoro-deoxy-glucoseAlso: PET with 18 FDG2 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 | Positron Emission Tomography |
Primary outcome
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
3 secondary outcomes
Change in SUVmax differences in the lesions according to their location in cured patients.
Time frame: 6 to 18 months
Variations ΣSUVmax and SUVmax in individual lesions in patients not cured.
Time frame: 6 to 18 months
Frequency, type and consequences on the therapeutic management of lesions revealed by FDG-PET.
Time frame: 6 to 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Yeni, MD, PHD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positron Emission Tomography with 18F-Fluoro-deoxy-glucose in people with Extrapulmonary Tuberculosis and Lymph Node Tuberculosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2018.