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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT01200771
First received: September 10, 2010
Last updated: February 17, 2014
Last verified: October 2012
  Purpose

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 Intervention
Fever
Procedure: TEP

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Limoges:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • To evaluate sensitivity and specificity of this diagnostic procedure [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • To analyse the cost effectiveness of this diagnostic approach [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 116
Study Start Date: May 2008
Study Completion Date: February 2014
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
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.
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01200771

Locations
France
Médecine Interne - CHU
Amiens, France, 80080
Médecine Nucléaire - CHU
Amiens, France, 80080
Médecine Interne - CHU
Lille, France, 59037
Médecine Nucléaire et Imagerie Fonctionnelle - CHU
Lille, France, 59037
Médecine Interne - CHU
Limoges, France, 87042
Médecine Nucléaire - CHU
Limoges, France, 87042
Médecine Nucléaire - AP-HP - Hôpital Hôtel Dieu
Paris, France, 75004
Médecine Interne - AP-HP - Hôpital Cochin
Paris, France, 75014
Médecine Interne - AP-HP - Hôpital Hôtel Dieu
Paris, France, 75004
Médecine Interne - AP-HP - La Pitié Salpétrière
Paris, France, 75013
Médecine Nucléaire - AP-HP - Hôpital Bichat
Paris, France, 75018
Médecine Nucléaire - AP-HP - La Pitié Salpétrière
Paris, France, 75013
Médecine Interne - AP-HP - Hôpital Bichat
Paris, France, 75018
Département de Médecine pour adulte - CHU
Rennes, France, 35056
Service des Isotopes - CRLCC Centre Eugène Marquis
Rennes, France, 35042
Médecine Interne - CH
Rodez, France, 12000
Médecine Nucléaire - CH
Rodez, France, 12000
Médecine Nucléaire - CHU
Toulouse, France, 31059
Médecine Interne - CHU
Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Limoges
Investigators
Principal Investigator: Kim LY, MD University Hospital, Limoges
  More Information

No publications provided

Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT01200771     History of Changes
Other Study ID Numbers: I07005 FUO TEP
Study First Received: September 10, 2010
Last Updated: February 17, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Limoges:
FDG-PET/CT
FUO
Chronic Inflammatory syndrome
Fever of unknown origin

Additional relevant MeSH terms:
Fever
Syndrome
Body Temperature Changes
Disease
Pathologic Processes
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014