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FeverFUO-TEPNCT01200771

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

A study testing TEP in people with Fever, run by University Hospital, Limoges at 19 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Fever
What is being tested?
TEP
How many people
116 participants
Where
19 sitesFrance
Study dates
May 2008to Feb 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

France19 sites

  • 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 Interne - AP-HP - Hôpital Hôtel Dieu

    Paris, France, 75004

  • Médecine Nucléaire - AP-HP - Hôpital Hôtel Dieu

    Paris, France, 75004

  • Médecine Interne - AP-HP - La Pitié Salpétrière

    Paris, France, 75013

  • Médecine Nucléaire - AP-HP - La Pitié Salpétrière

    Paris, France, 75013

  • Médecine Interne - AP-HP - Hôpital Cochin

    Paris, France, 75014

  • Médecine Interne - AP-HP - Hôpital Bichat

    Paris, France, 75018

  • Médecine Nucléaire - AP-HP - Hôpital Bichat

    Paris, France, 75018

  • Service des Isotopes - CRLCC Centre Eugène Marquis

    Rennes, France, 35042

  • Département de Médecine pour adulte - CHU

    Rennes, France, 35056

  • Médecine Interne - CH

    Rodez, France, 12000

  • Médecine Nucléaire - CH

    Rodez, France, 12000

  • Médecine Interne - CHU

    Toulouse, France, 31059

  • Médecine Nucléaire - CHU

    Toulouse, France, 31059

Other trials in France

About this study

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

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.

Read the 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

Conditions
Fever
Being tested
TEP
Keywords
FDG-PET/CT, FUO, Chronic Inflammatory syndrome, Fever of unknown origin
Medical subject headings
Fever, Fever of Unknown Origin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TEPProcedure or surgery

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To assess the contribution of FDG-PET/CT in the early diagnostic work-up of patients with FUO or chronic inflammatory syndrome

    Measured: 3 month

Secondary outcomes (3)

  1. 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.

    Measured: 3 months

  2. To evaluate sensitivity and specificity of this diagnostic procedure

    Measured: 3 months

  3. To analyse the cost effectiveness of this diagnostic approach

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2010 (estimated)
  2. Study startMay 2008
  3. Primary completionMay 2012
  4. Study completionFeb 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
116 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01200771
Sponsor's protocol ID
I07005 FUO TEP
Acronym
FUO-TEP
Status last verified
Jul 2025
First submitted
10 Sep 2010
Last updated
20 Jul 2025
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 35054081

Questions about this trial

What is this clinical trial studying?

A study testing TEP in people with Fever, run by University Hospital, Limoges at 19 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01200771, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2025.

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