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

Impact of the PET-scan in the Diagnosis Strategy of Fever Unknown Origin or Inflammatory Syndrome in Immunocompetent Patients

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.

Study Overview

• Status: Completed
• Conditions: Fever
• Intervention / Treatment: Procedure: TEP

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 Type: Interventional
• Enrollment (Actual): 116
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80080
    • Médecine Interne - CHU
  • Amiens, France, 80080
    • Médecine Nucléaire - CHU
  • Lille, France, 59037
    • Médecine Interne - CHU
  • Lille, France, 59037
    • Médecine Nucléaire et Imagerie Fonctionnelle - CHU
  • Limoges, France, 87042
    • Médecine Interne - CHU
  • Limoges, France, 87042
    • Médecine Nucléaire - CHU
  • Paris, France, 75004
    • Médecine Interne - AP-HP - Hôpital Hôtel Dieu
  • Paris, France, 75004
    • Médecine Nucléaire - AP-HP - Hôpital Hôtel Dieu
  • Paris, France, 75013
    • Médecine Interne - AP-HP - La Pitié Salpétrière
  • Paris, France, 75013
    • Médecine Nucléaire - AP-HP - La Pitié Salpétrière
  • Paris, France, 75014
    • Médecine Interne - AP-HP - Hôpital Cochin
  • Paris, France, 75018
    • Médecine Interne - AP-HP - Hôpital Bichat
  • Paris, France, 75018
    • Médecine Nucléaire - AP-HP - Hôpital Bichat
  • Rennes, France, 35042
    • Service des Isotopes - CRLCC Centre Eugène Marquis
  • Rennes, France, 35056
    • Département de Médecine pour adulte - CHU
  • Rodez, France, 12000
    • Médecine Interne - CH
  • Rodez, France, 12000
    • Médecine Nucléaire - CH
  • Toulouse, France, 31059
    • Médecine Interne - CHU
  • Toulouse, France, 31059
    • Médecine Nucléaire - CHU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To assess the contribution of FDG-PET/CT in the early diagnostic work-up of patients with FUO or chronic inflammatory syndrome	3 month

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	3 months
To evaluate sensitivity and specificity of this diagnostic procedure	3 months
To analyse the cost effectiveness of this diagnostic approach	3 months

Collaborators and Investigators

• Sponsor: University Hospital, Limoges
• Investigators: Principal Investigator: Kim LY, MD, University Hospital, Limoges

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: September 10, 2010
• First Submitted That Met QC Criteria: September 13, 2010
• First Posted (Estimate): September 14, 2010

Study Record Updates

• Last Update Posted (Estimate): February 19, 2014
• Last Update Submitted That Met QC Criteria: February 17, 2014
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: FDG-PET/CT; FUO; Chronic Inflammatory syndrome; Fever of unknown origin
• Additional Relevant MeSH Terms: Body Temperature Changes; Fever
• Other Study ID Numbers: I07005 FUO TEP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No