Clinical trial NCT01200771: Impact of the PET in the Diagnosis Strategy of FUO or Inflammatory Syndrome in Immunocompetent Patients FUO-TEP
Official title: Impact of the PET-scan in the Diagnosis Strategy of Fever Unknown Origin or Inflammatory Syndrome in Immunocompetent Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fever
Keywords: FDG-PET/CT
FUO
Chronic Inflammatory syndrome
Fever of unknown origin
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2010-09-14
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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 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.

Primary outcomes:
measure: To assess the contribution of FDG-PET/CT in the early diagnostic work-up of patients with FUO or chronic inflammatory syndrome
timeFrame: 3 month
Secondary outcomes:
measure: 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.
timeFrame: 3 months
measure: To evaluate sensitivity and specificity of this diagnostic procedure
timeFrame: 3 months
measure: To analyse the cost effectiveness of this diagnostic approach
timeFrame: 3 months
Other outcomes:
Locations:
city: Amiens
country: France
facility: Médecine Interne - CHU
city: Amiens
country: France
facility: Médecine Nucléaire - CHU
city: Lille
country: France
facility: Médecine Interne - CHU
city: Lille
country: France
facility: Médecine Nucléaire et Imagerie Fonctionnelle - CHU
city: Limoges
country: France
facility: Médecine Interne - CHU
city: Limoges
country: France
facility: Médecine Nucléaire - CHU
city: Paris
country: France
facility: Médecine Interne - AP-HP - Hôpital Hôtel Dieu
city: Paris
country: France
facility: Médecine Nucléaire - AP-HP - Hôpital Hôtel Dieu
city: Paris
country: France
facility: Médecine Interne - AP-HP - La Pitié Salpétrière
city: Paris
country: France
facility: Médecine Nucléaire - AP-HP - La Pitié Salpétrière
city: Paris
country: France
facility: Médecine Interne - AP-HP - Hôpital Cochin
city: Paris
country: France
facility: Médecine Interne - AP-HP - Hôpital Bichat
city: Paris
country: France
facility: Médecine Nucléaire - AP-HP - Hôpital Bichat
city: Rennes
country: France
facility: Service des Isotopes - CRLCC Centre Eugène Marquis
city: Rennes
country: France
facility: Département de Médecine pour adulte - CHU
city: Rodez
country: France
facility: Médecine Interne - CH
city: Rodez
country: France
facility: Médecine Nucléaire - CH
city: Toulouse
country: France
facility: Médecine Interne - CHU
city: Toulouse
country: France
facility: Médecine Nucléaire - CHU
Study officials:
affiliation: University Hospital, Limoges
name: Kim LY, MD
role: PRINCIPAL_INVESTIGATOR
References: