Application of radiomics for diagnosis and follow-up of cardiovascular device infections: PREDICT study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

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

Participant type

Healthy volunteers, Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Virus Diseases [C02]

Decision date (initial)

2026-04-07

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Instituto de Salud Carlos III (PI24/00730)

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

To assess the diagnostic performance of radiomics applied to FDG-PET in patients with CVDIs, in comparison with standard visual and semiquantitative analysis.

Secondary objectives 4

1. To evaluate the role of radiomics in monitoring suppressive antimicrobial therapy in patients with retained infected devices.
2. To identify normal 18F-FDG uptake patterns in cardiovascular devices in patients without suspected infection, stratified by sex and time from device implantation.
3. To develop and validate AI-based predictive models that integrate radiomic, clinical, demographic, and prognostic data for diagnosis, monitoring, and decision-making in CVDI management.
4. To evaluate the predictive accuracy of these AI-driven models in determining infection resolution and appropriate discontinuation of suppressive antimicrobial therapy.

Conditions and MedDRA coding

Cardiovascular device infections

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Age ≥ 18 years.
2. Implanted cardiovascular device (prosthetic valve, TAVI, CIED, vascular graft/endograft).
3. For infected cohorts: patients studied by FDG-PET with definitive diagnosis of CVDI based on multidisciplinary evaluation.
4. For control group: no clinical suspicion of infection at time of inclusion.
5. Written Informed consent provided (prospective cohort and control group).
6. 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 5

1. Inability to undergo FDG-PET due to contraindications (e.g., allergies, claustrophobia).
2. Pregnancy or breastfeeding.
3. Incomplete clinical data or lack of access to imaging studies.
4. Refusal or withdrawal of informed consent (for control and prospective cohort).
5. FDG-PET studies that fail to meet the required quality standards.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Diagnostic accuracy of radiomics applied to FDG-PET for CVDIs, compared with conventional visual and semiquantitative interpretation.

Secondary endpoints 2

1. 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.
2. Characterization of physiological 18F-FDG uptake patterns in cardiovascular device carriers without infection, stratified by sex and time since implantation.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

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

Sponsor organisation

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

Address

Calle Rosellon 149-153

City

Barcelona

Postcode

08036

Country

Spain

Scientific contact point

Organisation

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

Contact name

Dra. Marta Hernández-Meneses

Public contact point

Organisation

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

Contact name

Dra. Marta Hernández-Meneses

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications