FLUDEOXYGLUCOSE (18F) for Cardiovascular device infections | Device related infection

Inclusion criteria

• {"criterion_text":"- Age ≥ 18 years.\n- Implanted cardiovascular device (prosthetic valve, TAVI, CIED, vascular graft/endograft).\n- For infected cohorts: patients studied by FDG-PET with definitive diagnosis of CVDI based on multidisciplinary evaluation.\n- For control group: no clinical suspicion of infection at time of inclusion.\n- Written Informed consent provided (prospective cohort and control group).\n- Women of child-bearing potential must have a negative pregnancy test in serum or urine before the inclusion in the study and agree to use highly effective contraceptive methods during the study. Highly effective contraceptive methods will include: intrauterine device, bilateral tubal occlusion, vasectomized partner and sexual abstinence (only if refraining from heterosexual intercourse during the period of twelve months of duration of the study)."}

Exclusion criteria

• {"criterion_text":"- Inability to undergo FDG-PET due to contraindications (e.g., allergies, claustrophobia).\n- Pregnancy or breastfeeding.\n- Incomplete clinical data or lack of access to imaging studies.\n- Refusal or withdrawal of informed consent (for control and prospective cohort).\n- FDG-PET studies that fail to meet the required quality standards."}

Primary endpoints

• {"endpoint_text":"- Diagnostic accuracy of radiomics applied to FDG-PET for CVDIs, compared with conventional visual and semiquantitative interpretation.","definition_or_measurement_approach":"Assessment of diagnostic accuracy of radiomics applied to FDG-PET compared with conventional visual and semiquantitative interpretation (as stated in endpoint). Specific metrics or thresholds not specified in the record."}

Secondary endpoints

• {"endpoint_text":"- Performance of AI-based predictive models (combining radiomic and clinical features) for: o Distinguishing infection vs. non-infection. o Predicting resolution of infection and supporting discontinuation of suppressive antimicrobial therapy.","definition_or_measurement_approach":"Evaluation of AI-based predictive models combining radiomic and clinical features to distinguish infection vs non-infection and to predict infection resolution/support discontinuation of suppressive antimicrobial therapy. Specific performance metrics not provided."}
• {"endpoint_text":"- Characterization of physiological 18F-FDG uptake patterns in cardiovascular device carriers without infection, stratified by sex and time since implantation.","definition_or_measurement_approach":"Characterisation of normal 18F-FDG uptake patterns in patients without suspected infection, stratified by sex and time since device implantation. Specific measurement methods not detailed."}

Spain

Earliest CTIS Part Ii Submission Date

12-03-2026

Latest Decision Or Authorization Date

07-04-2026

Processing Time Days

26

Number Of Sites

1

Number Of Participants

200

Primary sponsor

Full Name

Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Spain

Third parties

• {"country":"","full_name":"Instituto de Salud Carlos III (PI24/00730)","duties_or_roles":"Monetary support / funding","organisation_type":""}