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PET/CT in Extrapulmonary TB in HIV Patients: a Clinical Trial

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ClinicalTrials.gov Identifier: NCT02822014
Recruitment Status : Completed
First Posted : July 4, 2016
Last Update Posted : July 4, 2016
Sponsor:
Information provided by (Responsible Party):
Charlotte Martin, Centre Hospitalier Universitaire Saint Pierre

Brief Summary:

Objective Prospectively describe the kinetics of 18F-FDG uptake of extrapulmonary TB after two months and at the end of TB treatment in HIV patients. Evaluate 18F-FDG-PET/CT as a TB treatment response monitoring tool.

Design The investigators performed baseline FDG-PET/CT, another FDG-PET/CT after 2 months of TB treatment and a PET/CT at the end of treatment in 18 HIV/TB patients. The investigators correlated evolution of FDG uptake with clinical evolution of patients.


Condition or disease Intervention/treatment Phase
Extrapulmonary Tuberculosis in HIV Patients Other: FDG-PET/CT Not Applicable

Detailed Description:

Materials and Methods Eighteen HIV-positive patients, 18 years old or more, with extra pulmonary TB were enrolled after providing written informed consent. Baseline FDG-PET/CT was performed before or as soon as possible after initiating TB treatment, followed by FDG-PET/CT after 2 months of TB treatment and at the end of TB treatment according to guidelines (6 months/9-12 months if bone or CNS TB). However, real duration of treatment was left at the discretion of physician, blinded to the results of second and third FDG-PET/CT.

Patients Collected data were: demographics, mode of HIV infection, nadir CD4 cell count, history/date of cART start, mode/date of TB diagnosis, HIV immunovirological status at the time of TB diagnosis, date of TB treatment, culture and DST (Drug Susceptibility Test) results for M. tuberculosis, histopathology results, IRIS (immune reconstitution inflammatory syndrome, documented by treating physician), corticosteroids administration and TB relapse during a follow-up of at least 36 months after the end of TB treatment. TB was classified as proven if culture, molecular biology (PCR) was positive for M. tuberculosis/ histopathology showed caseous granulomatosis, or probable if the patient improved with TB treatment without other diagnosis and an additional criterium (i.e. CSF analysis compatible with TB meningitis, biopsy showing granulomas). Clinical and biological follow up was performed every 4 months during at least 36 months.

FDG-PET/CT analysis Two experienced nuclear medicine physicians, blinded to clinical, bacteriological and histopathological findings, interpreted FDG-PET/CT images. They followed a predefined reading frame, looking first at 9 lymph node sites (cervical, axillary, mediastinal, hilar, retroperitoneal, portal-hepatic, mesenteric, iliac, inguinal) then at other FDG uptake including organ. A site was designated as abnormal if FDG activity was increased relative to that of adjacent normal soft-tissue. The number of abnormal sites (lymph node sites and organs) was counted. Qualitative assessment was made by Visual score for each site: score 1 was defined as less than 5 visible active lymph nodes, score 2 as 5 to 10 visible active lymph nodes and score 3 as too much lymph nodes to count, or massive confluence of lymph nodes at a site. The 3 greatest lymph node sites per patient in terms of visual score were described in detail in our analysis.

FDG-PET were quantitatively analyzed using SUVmax. SUVmax corresponds to the maximum Standardized Uptake Value (SUV) in a voxel within a circular region of interest drawn manually for each site showing FDG uptake. SUVmax was measured on the most active lymph node in each lymph node site. Concerning organ FDG uptake, only SUVmax of the most active organ was described. Percentage change in SUVmax between serial FDG-PET/CT (or DeltaSUVmax) was calculated as follows: %DSUVmax = (SUVmaxT0 - SUVmaxT2) / SUVmaxT0 x 100 (with T0 the baseline FDG-PET/CT and T2 either PET2 or PET3). DeltaSUVmax was considered significant when ≥ 20%. In our analysis, the PET2 performed after 2 months of TB treatment was compared to the baseline FDG-PET/CT (PET1). PET3, performed at the end of TB treatment, was compared to PET1.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: FDG-PET/CT: a Tool in Diagnosis and Treatment Response Monitoring of Extrapulmonary Tuberculosis in HIV Patients
Study Start Date : February 2010
Actual Primary Completion Date : January 2013
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
FDG-PET/CT arm
We performed baseline FDG-PET/CT, another FDG-PET/CT after 2 months of TB treatment and a PET/CT at the end of treatment in 18 HIV/TB patients. We correlated evolution of FDG uptake with clinical evolution of patients.
Other: FDG-PET/CT
We performed baseline FDG-PET/CT, another FDG-PET/CT after 2 months of TB treatment and a PET/CT at the end of treatment in 18 HIV/TB patients.




Primary Outcome Measures :
  1. clinical evolution of TB/HIV patients: cure or relapse within 36 months of follow-up with relapse documented microbiologically [ Time Frame: 36 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV-infected patient
  • aged at least 18 years old
  • with high clinical suspicion of extrapulmonary tuberculosis

Exclusion Criteria:

  • predominant neurological symptoms
  • pregnancy
  • positive smear sputum for tuberculosis
  • MDR or XDR tuberculosis

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Responsible Party: Charlotte Martin, Medical Doctor, Centre Hospitalier Universitaire Saint Pierre
ClinicalTrials.gov Identifier: NCT02822014     History of Changes
Other Study ID Numbers: AK/09-09-52/3810
First Posted: July 4, 2016    Key Record Dates
Last Update Posted: July 4, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections