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

Fever Clinical Trial

— FUO-TEP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01200771
• Other study ID #: I07005 FUO TEP
• Status: Completed
• Phase: N/A
• First received: September 10, 2010
• Last updated: February 17, 2014
• Start date: May 2008
• Est. completion date: February 2014

Study information

• Verified date: October 2012
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: February 2014
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Fever

Intervention

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.

Locations

Country	Name	City	State
France	Médecine Interne - CHU	Amiens
France	Médecine Nucléaire - CHU	Amiens
France	Médecine Interne - CHU	Lille
France	Médecine Nucléaire et Imagerie Fonctionnelle - CHU	Lille
France	Médecine Interne - CHU	Limoges
France	Médecine Nucléaire - CHU	Limoges
France	Médecine Interne - AP-HP - Hôpital Bichat	Paris
France	Médecine Interne - AP-HP - Hôpital Cochin	Paris
France	Médecine Interne - AP-HP - Hôpital Hôtel Dieu	Paris
France	Médecine Interne - AP-HP - La Pitié Salpétrière	Paris
France	Médecine Nucléaire - AP-HP - Hôpital Bichat	Paris
France	Médecine Nucléaire - AP-HP - Hôpital Hôtel Dieu	Paris
France	Médecine Nucléaire - AP-HP - La Pitié Salpétrière	Paris
France	Département de Médecine pour adulte - CHU	Rennes
France	Service des Isotopes - CRLCC Centre Eugène Marquis	Rennes
France	Médecine Interne - CH	Rodez
France	Médecine Nucléaire - CH	Rodez
France	Médecine Interne - CHU	Toulouse
France	Médecine Nucléaire - CHU	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the contribution of FDG-PET/CT in the early diagnostic work-up of patients with FUO or chronic inflammatory syndrome		3 month	No
Secondary	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	No
Secondary	To evaluate sensitivity and specificity of this diagnostic procedure		3 months	No
Secondary	To analyse the cost effectiveness of this diagnostic approach		3 months	No