NCT01200771

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 14, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

July 20, 2025

Status Verified

July 1, 2025

Enrollment Period

4 years

First QC Date

September 10, 2010

Last Update Submit

July 17, 2025

Conditions

Fever

Keywords

FDG-PET/CTFUOChronic Inflammatory syndromeFever of unknown origin

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

Interventions

TEPPROCEDURE

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Médecine Interne - CHU

Amiens, France, 80080, France

Location

Médecine Nucléaire - CHU

Amiens, France, 80080, France

Location

Médecine Interne - CHU

Lille, France, 59037, France

Location

Médecine Nucléaire et Imagerie Fonctionnelle - CHU

Lille, France, 59037, France

Location

Médecine Interne - CHU

Limoges, France, 87042, France

Location

Médecine Nucléaire - CHU

Limoges, France, 87042, France

Location

Médecine Interne - AP-HP - Hôpital Hôtel Dieu

Paris, France, 75004, France

Location

Médecine Nucléaire - AP-HP - Hôpital Hôtel Dieu

Paris, France, 75004, France

Location

Médecine Interne - AP-HP - La Pitié Salpétrière

Paris, France, 75013, France

Location

Médecine Nucléaire - AP-HP - La Pitié Salpétrière

Paris, France, 75013, France

Location

Médecine Interne - AP-HP - Hôpital Cochin

Paris, France, 75014, France

Location

Médecine Interne - AP-HP - Hôpital Bichat

Paris, France, 75018, France

Location

Médecine Nucléaire - AP-HP - Hôpital Bichat

Paris, France, 75018, France

Location

Service des Isotopes - CRLCC Centre Eugène Marquis

Rennes, France, 35042, France

Location

Département de Médecine pour adulte - CHU

Rennes, France, 35056, France

Location

Médecine Interne - CH

Rodez, France, 12000, France

Location

Médecine Nucléaire - CH

Rodez, France, 12000, France

Location

Médecine Interne - CHU

Toulouse, France, 31059, France

Location

Médecine Nucléaire - CHU

Toulouse, France, 31059, France

Location

Related Publications (1)

  • 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.

    PMID: 35054081BACKGROUND

MeSH Terms

Conditions

FeverFever of Unknown Origin

Interventions

tetraethylpyrazine

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kim LY, MD

    University Hospital, Limoges

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2010

First Posted

September 14, 2010

Study Start

May 1, 2008

Primary Completion

May 1, 2012

Study Completion

February 1, 2014

Last Updated

July 20, 2025

Record last verified: 2025-07

Locations

FR(19)