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

NCT ID: NCT01200771

Last Updated: 2025-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2014-02-28

Brief Summary

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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

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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

Conditions

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Fever

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Limoges

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kim LY, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Limoges

Locations

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Médecine Interne - CHU

Amiens, France, France

Site Status

Médecine Nucléaire - CHU

Amiens, France, France

Site Status

Médecine Interne - CHU

Lille, France, France

Site Status

Médecine Nucléaire et Imagerie Fonctionnelle - CHU

Lille, France, France

Site Status

Médecine Interne - CHU

Limoges, France, France

Site Status

Médecine Nucléaire - CHU

Limoges, France, France

Site Status

Médecine Interne - AP-HP - Hôpital Hôtel Dieu

Paris, France, France

Site Status

Médecine Nucléaire - AP-HP - Hôpital Hôtel Dieu

Paris, France, France

Site Status

Médecine Interne - AP-HP - La Pitié Salpétrière

Paris, France, France

Site Status

Médecine Nucléaire - AP-HP - La Pitié Salpétrière

Paris, France, France

Site Status

Médecine Interne - AP-HP - Hôpital Cochin

Paris, France, France

Site Status

Médecine Interne - AP-HP - Hôpital Bichat

Paris, France, France

Site Status

Médecine Nucléaire - AP-HP - Hôpital Bichat

Paris, France, France

Site Status

Service des Isotopes - CRLCC Centre Eugène Marquis

Rennes, France, France

Site Status

Département de Médecine pour adulte - CHU

Rennes, France, France

Site Status

Médecine Interne - CH

Rodez, France, France

Site Status

Médecine Nucléaire - CH

Rodez, France, France

Site Status

Médecine Interne - CHU

Toulouse, France, France

Site Status

Médecine Nucléaire - CHU

Toulouse, France, France

Site Status

Countries

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France

References

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Ly KH, Costedoat-Chalumeau N, Liozon E, Dumonteil S, Ducroix JP, Sailler L, Lidove O, Bienvenu B, Decaux O, Hatron PY, Smail A, Astudillo L, Morel N, Boutemy J, Perlat A, Denes E, Lambert M, Papo T, Cypierre A, Vidal E, Preux PM, Monteil J, Fauchais AL. Diagnostic Value of 18F-FDG PET/CT vs. Chest-Abdomen-Pelvis CT Scan in Management of Patients with Fever of Unknown Origin, Inflammation of Unknown Origin or Episodic Fever of Unknown Origin: A Comparative Multicentre Prospective Study. J Clin Med. 2022 Jan 13;11(2):386. doi: 10.3390/jcm11020386.

Reference Type BACKGROUND
PMID: 35054081 (View on PubMed)

Other Identifiers

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I07005 FUO TEP

Identifier Type: -

Identifier Source: org_study_id

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