Diagnosis of infection in prothesis by 18F-FDG-WBC-PET/CT

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001607-36-SE

Enrollment

115

Registered

2013-06-26

Start date

2013-08-23

Completion date

Unknown

Last updated

2021-06-07

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

Conditions

orthopedic prothesis

Interventions

Trade Name: FDG Product Name: INN= fluordeoxiglykos (F-18) Product Code: MA number 44635 Pharmaceutical Form: Injection Trade Name: CERETEC, INN-exametazime, MA number =80004 Product Name: 99mTc-HMPA

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.suspected infection in orthopedic prothesis. 2 newly inplanted orthopedic divices 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 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 105

Exclusion criteria

Exclusion criteria: pregnancy, lactation

Design outcomes

Primary

Measure	Time frame
Main Objective: The accuracy in the diagnosis of infection;Secondary Objective: Natural evolution after orthopedic surgery;Primary end point(s): Follow up ;Timepoint(s) of evaluation of this end point: 2 years	—

Secondary

Measure	Time frame
Secondary end point(s): same;Timepoint(s) of evaluation of this end point: same	—

Countries

Sweden

Contacts

Public Contactverksamhetschef

SLL

leif.svensson@karolinska.se

Outcome results

None listed

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