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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-005373-58-IT

Enrollment

Registered

2007-10-12

Start date

2007-09-18

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Product Name: 68 Gallium Citrate Pharmaceutical Form: Solution for infusion Other descriptive name: Gallium Citrate Concentration unit: Bq/l becquerel(s)/litre Concentration type: equal Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: 1. Age < 18 years 2. On-going antibiotic, anti-inflammatory and immunosoppressive therapy. 3. Pregnancy.

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026