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

Primary Purpose

Fever

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
TEP
Sponsored by
University Hospital, Limoges
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Fever focused on measuring FDG-PET/CT, FUO, Chronic Inflammatory syndrome, Fever of unknown origin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Médecine Interne - CHU
  • Médecine Nucléaire - CHU
  • Médecine Interne - CHU
  • Médecine Nucléaire et Imagerie Fonctionnelle - CHU
  • Médecine Interne - CHU
  • Médecine Nucléaire - CHU
  • Médecine Interne - AP-HP - Hôpital Hôtel Dieu
  • Médecine Nucléaire - AP-HP - Hôpital Hôtel Dieu
  • Médecine Interne - AP-HP - La Pitié Salpétrière
  • Médecine Nucléaire - AP-HP - La Pitié Salpétrière
  • Médecine Interne - AP-HP - Hôpital Cochin
  • Médecine Interne - AP-HP - Hôpital Bichat
  • Médecine Nucléaire - AP-HP - Hôpital Bichat
  • Service des Isotopes - CRLCC Centre Eugène Marquis
  • Département de Médecine pour adulte - CHU
  • Médecine Interne - CH
  • Médecine Nucléaire - CH
  • Médecine Interne - CHU
  • Médecine Nucléaire - CHU

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
To evaluate sensitivity and specificity of this diagnostic procedure
To analyse the cost effectiveness of this diagnostic approach

Full Information

First Posted
September 10, 2010
Last Updated
February 17, 2014
Sponsor
University Hospital, Limoges
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1. Study Identification

Unique Protocol Identification Number
NCT01200771
Brief Title
Impact of the PET in the Diagnosis Strategy of FUO or Inflammatory Syndrome in Immunocompetent Patients FUO-TEP
Acronym
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

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Limoges

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fever
Keywords
FDG-PET/CT, FUO, Chronic Inflammatory syndrome, Fever of unknown origin

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
TEP
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
To evaluate sensitivity and specificity of this diagnostic procedure
Time Frame
3 months
Title
To analyse the cost effectiveness of this diagnostic approach
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim LY, MD
Organizational Affiliation
University Hospital, Limoges
Official's Role
Principal Investigator
Facility Information:
Facility Name
Médecine Interne - CHU
City
Amiens
ZIP/Postal Code
80080
Country
France
Facility Name
Médecine Nucléaire - CHU
City
Amiens
ZIP/Postal Code
80080
Country
France
Facility Name
Médecine Interne - CHU
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Médecine Nucléaire et Imagerie Fonctionnelle - CHU
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Médecine Interne - CHU
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Médecine Nucléaire - CHU
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Médecine Interne - AP-HP - Hôpital Hôtel Dieu
City
Paris
ZIP/Postal Code
75004
Country
France
Facility Name
Médecine Nucléaire - AP-HP - Hôpital Hôtel Dieu
City
Paris
ZIP/Postal Code
75004
Country
France
Facility Name
Médecine Interne - AP-HP - La Pitié Salpétrière
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Médecine Nucléaire - AP-HP - La Pitié Salpétrière
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Médecine Interne - AP-HP - Hôpital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Médecine Interne - AP-HP - Hôpital Bichat
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Médecine Nucléaire - AP-HP - Hôpital Bichat
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Service des Isotopes - CRLCC Centre Eugène Marquis
City
Rennes
ZIP/Postal Code
35042
Country
France
Facility Name
Département de Médecine pour adulte - CHU
City
Rennes
ZIP/Postal Code
35056
Country
France
Facility Name
Médecine Interne - CH
City
Rodez
ZIP/Postal Code
12000
Country
France
Facility Name
Médecine Nucléaire - CH
City
Rodez
ZIP/Postal Code
12000
Country
France
Facility Name
Médecine Interne - CHU
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Médecine Nucléaire - CHU
City
Toulouse
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

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

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