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Impact of the PET in the Diagnosis Strategy of FUO or Inflammatory Syndrome in Immunocompetent Patients FUO-TEP (FUO-TEP)

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ClinicalTrials.gov Identifier: NCT01200771
Recruitment Status : Completed
First Posted : September 14, 2010
Last Update Posted : February 19, 2014
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges

Study Description
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Brief Summary:
Fever of unknown origin (FUO) and chronic inflammatory syndrome could be seen in many affections. The diagnostic process is still a challenge and could not be specified yet after several clinical studies performed by trained teams using two levels diagnostic procedures. For this reason, the diagnosis involves many additional and expensive tests such as computed tomography (CT scan), scintigraphic imaging, endoscopy, biopsy. There is no evidence-based recommendation for the diagnostic work-up of FUO or chronic inflammatory syndrome. Positron emission tomography with 2-[18F] fluoro-2-deoxy-D-glucose combined with CT scan (FDG-PET/CT) is widely used in malignant diseases and seems to be promising for the diagnosis of inflammatory disorders. Its role has not been yet clearly defined in the investigation of FUO and chronic inflammatory syndrome.

Condition or disease Intervention/treatment Phase
Fever Procedure: TEP Not Applicable

Detailed Description:

All patients with FUO and chronic inflammatory syndrome will undergo FDG-PET/CT and conventional morphologic imaging modalities. Results of these two diagnostic procedures in identifying diagnostic clues will be compared.

We assume FDG-PET/CT could be safer and more helpful to reach early final diagnosis in patients with FUO and chronic inflammatory syndrome than conventional morphologic imaging modalities

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Impact of the PET-scan in the Diagnosis Strategy of Fever Unknown Origin or Inflammatory Syndrome in Immunocompetent Patients
Study Start Date : May 2008
Actual Primary Completion Date : May 2012
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Arms and Interventions
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Intervention Details:
  • Procedure: TEP
    Intravenous injection of glucose labeled Fluor 18. The patient remains fasted at least 6 hours before the start of the examination. The review lasted 1 hour, during wich the patient should not move.

Outcome Measures
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Primary Outcome Measures :
  1. To assess the contribution of FDG-PET/CT in the early diagnostic work-up of patients with FUO or chronic inflammatory syndrome [ Time Frame: 3 month ]

Secondary Outcome Measures :
  1. To establish the role of FGD PET in reaching final diagnosis compared to conventional morphologic imaging modalities including computer tomography and gallium-67 citrate scintigraphy. [ Time Frame: 3 months ]
  2. To evaluate sensitivity and specificity of this diagnostic procedure [ Time Frame: 3 months ]
  3. To analyse the cost effectiveness of this diagnostic approach [ Time Frame: 3 months ]

Eligibility Criteria
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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:

  • Patient with FUO criteria:

Fever since 3 weeks, Temperature > 38.3°C, No diagnostic after 3 days of hospitalization.

  • Patient with periodic fever criteria:

Fever with criteria like FUO, Fever-free intervals, and apparent remission of the underlying disease, At least 3 febrile episodes.

  • Inflammatory syndrome without any clinical sign, Important inflammatory syndrome: Erythrocyte sedimentation rate ≥ 50 at the first hour, and elevation of at least one another inflammatory parameter (haptoglobin, orosomucoïd, fibrinogen or C-reactive protein), Evolution since more than 3 weeks, No diagnostic orientation after clinical examination and history-taking, No diagnostic clue after 3 days of hospitalisation.
  • Oral informed consent obtained.

Exclusion Criteria:

  • Demented patient or unable to receive information on the protocol and to give informed consent.
  • Pregnant women, or without contraception.
  • Contraindication to iodine examination, gallium scintigraphy or 18FDG TEP-scan.
  • Immunodeficient patient.
  • Know HIV infection, neutropenic patient and nosocomial fever.
Contacts and Locations
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Information from the National Library of Medicine

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): NCT01200771


Locations
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Sponsors and Collaborators
University Hospital, Limoges
Investigators
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Principal Investigator: Kim LY, MD University Hospital, Limoges
More Information
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Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT01200771    
Other Study ID Numbers: I07005 FUO TEP
First Posted: September 14, 2010    Key Record Dates
Last Update Posted: February 19, 2014
Last Verified: October 2012
Keywords provided by University Hospital, Limoges:
FDG-PET/CT
FUO
Chronic Inflammatory syndrome
Fever of unknown origin
Additional relevant MeSH terms:
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Fever
Body Temperature Changes