EVALUATION OF DIAGNOSTIC ACCURACY OF 68GA-CITRATE PET/CT IN PATIENTS WITH INFLAMMATORY-INFECTIOUS DISEASES. - ND

Active, not recruiting

Conditions: Inflammatory disease
MedDRA version: 9.1Level: HLTClassification code 10005941Term: Bone and joint infections (excl arthritis)

Registration Number: EUCTR2007-005373-58-IT

Lead Sponsor: AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1.Patients must be affected by: infected hip prosthesis, infected knee prosthesis, diabetic foot infection, spondilodiscitis, granulomatous pulmonary diseases, inflammatory bowel diseases, vasculitis, without antibiotic, anti-inflammatory and immunosoppressive therapy.

2.Age  18 years.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Age < 18 years

2.On-going antibiotic, anti-inflammatory and immunosoppressive therapy.

3.Pregnancy.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary aim of the study is to assess a preliminary evaluation of the accuracy of 68Ga-citrate PET/CT imaging on 25 patients affected by various inflammatory-infectious diseases, and compare it with the accuracy of 67Ga-cytrate scintigraphy reported in literature (SENS 70%, SPEC 90%).;Secondary Objective: None declared;Primary end point(s): To demonstrate the higher accuracy using PET/TC with 68 Ga Citrate

Secondary Outcome Measures