Impact of the PET in the Diagnosis Strategy of FUO or Inflammatory Syndrome in Immunocompetent Patients FUO-TEP
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Fever |
Procedure: TEP |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Impact of the PET-scan in the Diagnosis Strategy of Fever Unknown Origin or Inflammatory Syndrome in Immunocompetent Patients |
- 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 ] [ Designated as safety issue: No ]
- 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. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- To evaluate sensitivity and specificity of this diagnostic procedure [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- To analyse the cost effectiveness of this diagnostic approach [ Time Frame: 3 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | February 2013 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
-
Procedure: TEP
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| France | |
| 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 Nucléaire - CHU | |
| Limoges, France, 87042 | |
| Médecine Interne - CHU | |
| Limoges, France, 87042 | |
| Médecine Nucléaire - AP-HP - Hôpital Bichat | |
| Paris, France, 75018 | |
| Médecine Interne - AP-HP - Hôpital Bichat | |
| Paris, France, 75018 | |
| Médecine Nucléaire - AP-HP - Hôpital Hôtel Dieu | |
| Paris, France, 75004 | |
| Médecine Interne - 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 | |
| Département de Médecine pour adulte - CHU | |
| Rennes, France, 35056 | |
| Service des Isotopes - CRLCC Centre Eugène Marquis | |
| Rennes, France, 35042 | |
| Médecine Interne - CH | |
| Rodez, France, 12000 | |
| Médecine Nucléaire - CH | |
| Rodez, France, 12000 | |
| Médecine Interne - CHU | |
| Toulouse, France, 31059 | |
| Médecine Nucléaire - CHU | |
| Toulouse, France, 31059 | |
| Principal Investigator: | Kim LY, MD | University Hospital, Limoges |
More Information
No publications provided
| Responsible Party: | Marie SENGELEN |
| ClinicalTrials.gov Identifier: | NCT01200771 History of Changes |
| Other Study ID Numbers: | . I07005 |
| Study First Received: | September 10, 2010 |
| Last Updated: | October 22, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by University Hospital, Limoges:
|
FDG-PET/CT FUO Chronic Inflammatory syndrome Fever of unknown origin |
Additional relevant MeSH terms:
|
Fever Body Temperature Changes Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013