Somatostatin receptor PET study (68Ga-DOTATOC) for the diagnosis of infectious ENDOcarditis

Early feasibility study of somatostatin receptor (68Ga-DOTATOC) PET imaging for the diagnosis of infectious ENDOcarditis - DOTENDO

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-006660-25-FR

Enrollment

Registered

2021-12-23

Start date

2022-03-08

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

infective endocarditis MedDRA version: 20.0 Level: LLT Classification code 10000667 Term: Acute and subacute infective endocarditis in diseases classified elsewhere System Organ Class: 100000004862

Interventions

Trade Name: SOMAKIT TOC 40 microgrammes Product Name: SOMAKIT Pharmaceutical Form: Kit for radiopharmaceutical preparation Trade Name: FLUDESOXYGLUCOSE (18F) CURIUM Product Name: FLUDESOXYGLUCOSE (18

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Adult having received full information on the organization of the research and having signed informed consent. - Participant hospitalized for definite AR according to the modified Duke criteria (Li), on native or prosthetic valve, referred for 18F-FDG PET/CT by the Cardiology and Infectious Diseases departments 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 15 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Participant with a formal or relative contraindication to 68Ga DOTATOC PET/CT and/or 18F-FDG PET/CT - Impossibility to perform a 68Ga-DOTATOC PET scan (agitated, confused patient...). - Inability to schedule 68Ga-DOTATOC PET/CT the day after 18F-FDG PET/CT. - Participant treated with a somatostatin analogue. - Participant with Cushing's syndrome - Pregnant, likely to be pregnant or breastfeeding

Design outcomes

Primary

Measure	Time frame
Main Objective: To visually assess the detectability of cardiac and extracardiac foci in association with infective endocarditis (IE) on native or prosthetic valve by 68Ga-DOTATOC PET/CT ;Secondary Objective: 1.Quantify the uptake of 68Ga-DOTATOC at the site of infection by measuring the Standard Uptake Value (SUV) and the relationship with blood activity 2.Compare the results of 68Ga-DOTATOC PET/CT with those of 18F-FDG PET in terms of visual and quantitative analysis on whole body scans. 3.Compare the results of 68Ga-DOTATOC PET/CT with those of 18F-FDG PET, in terms of visual and quantitative analysis of cardiac step examinations. ;Primary end point(s): Presence of a visually detectable 68Ga-DOTATOC uptake zone in the cardiac and extra-cardiac foci. ;Timepoint(s) of evaluation of this end point: At centralized imaging at the end of the study	—

Measure

Time frame

Main Objective: To visually assess the detectability of cardiac and extracardiac foci in association with infective endocarditis (IE) on native or prosthetic valve by 68Ga-DOTATOC PET/CT ;Secondary Objective: 1.Quantify the uptake of 68Ga-DOTATOC at the site of infection by measuring the Standard Uptake Value (SUV) and the relationship with blood activity 2.Compare the results of 68Ga-DOTATOC PET/CT with those of 18F-FDG PET in terms of visual and quantitative analysis on whole body scans. 3.Compare the results of 68Ga-DOTATOC PET/CT with those of 18F-FDG PET, in terms of visual and quantitative analysis of cardiac step examinations. ;Primary end point(s): Presence of a visually detectable 68Ga-DOTATOC uptake zone in the cardiac and extra-cardiac foci. ;Timepoint(s) of evaluation of this end point: At centralized imaging at the end of the study

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Secondary

Measure	Time frame
Secondary end point(s): 1. Quantitative measurement(s) of 68Ga-DOTATOC uptake at the site(s) of infective endocarditis by Standard Uptake Value (SUV) and also by relationships with blood SUVs. 2. Results of visual and quantitative analysis of 68Ga-DOTATOC PET/CT and 18F-FDG PET scans on whole body examinations. 3. Results of visual analysis and quantitative analysis of 68Ga-DOTATOC PET/CT and 18F-FDG PET on cardiac step examination.;Timepoint(s) of evaluation of this end point: At centralized imaging at the end of the study	—

Measure

Time frame

Secondary end point(s): 1. Quantitative measurement(s) of 68Ga-DOTATOC uptake at the site(s) of infective endocarditis by Standard Uptake Value (SUV) and also by relationships with blood SUVs. 2. Results of visual and quantitative analysis of 68Ga-DOTATOC PET/CT and 18F-FDG PET scans on whole body examinations. 3. Results of visual analysis and quantitative analysis of 68Ga-DOTATOC PET/CT and 18F-FDG PET on cardiac step examination.;Timepoint(s) of evaluation of this end point: At centralized imaging at the end of the study

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Countries

France

Contacts

Public ContactRegulatory Project Manageur

CHRU de Nancy

a.hue@chru-nancy.fr

Outcome results

None listed

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