CHRU de NANCY
Vandœuvre-lès-Nancy, 54511, France
NCT Number: NCT05183555
Study hypothesis: 68Ga-DOTATOC PET/CT could detect cardiac foci of infective endocarditis regardless of the type of valve (native or prosthetic) and also extracardiac localizations related to this pathology (infection responsible, peripheral emboli, ...). This study is a proof of concept with low population
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All sexes
Interventional
Phase 2
Vandœuvre-lès-Nancy, 54511, France
The incidence of infective endocarditis (IE) in France is estimated to be around 30 cases per million inhabitants in studies conducted in Western countries and is significantly increased in patients with a valve prosthesis and even more so in cases of a history of endocarditis. The morbi-mortality is significant and the hospital mortality rate is 20%.
The diagnosis of IE remains difficult and according to the modified Duke criteria, the diagnostic sensitivity is 80%.
Currently, the diagnosis of IE is often determined according to the 2015 ESC criteria and the sensitivity increases from 57% to 84% regarding IE on prosthetic valves.
The 18F-FDG PET/CT examination is of major interest in the diagnosis of AR on prosthetic valves with a detection sensitivity of between 70 and 90% (with an accuracy of 70 to 80%). Concerning native valves, the sensitivity of PET/CT remains below 50%.
Indeed, a "physiological" myocardial fixation in 18F-FDG PET/CT compromises the interpretation of PET exam, so it is important to start a hypoglycemic-hyperlipidic diet the day before the 18F-FDG PET/CT, followed by a 12-hour fasting period.
For several years, a radiopharmaceutical, 68Ga-DOTATOC (68Ga-edotreotide) has been used in PET/CT for the diagnosis and follow-up of neuroendocrine tumours (NETs). 68Ga-DOTATOC binds mainly with high affinity to somatostatin receptor subtype 2 (SSTR2) but also to somatostatin receptor subtype 5 (SSTR5).
Activated monocytes, macrophages, and lymphocytes express somatostatin receptors , thus detection of SSTR2 receptors expressed by inflammatory cells could help for the diagnosis of infective endocarditis.
PET/CT with 68Ga-DOTATOC could thus detect inflammatory cells at infectious sites. This radiopharmaceutical has already shown an ability to identify a myocardial inflammation (inflammatory phase myocarditis and cardiac sarcoidosis).
In current study conducted by our teams (NCT03347760 on ClinicalTrials.gov), early results showed the capacity of the 68Ga-DOTATOC to detect efficiently myocarditis, including myocarditis induced by RNA anti-COVID vaccinations.
In vitro, the 18FDG uptake by inflammatory cells is more important than the 68Ga-DOTATOC uptake, but the contrast between infection focus and healthy tissue should be better since 68Ga-DOTATOC does not cause any physiological myocardial uptake. The 68Ga-DOTATOC does not required any special metabolic preparation or prolonged fasting often poorly supported by patients.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
68Ga-DOTATOC PET/CT will be recorded the following day of 18F-FDG PET/CT if patient signed the consent
Other names: 18F-FDG PET/CT
Time frame: one year
to visually evaluate the detectability of cardiac and extracardiac foci associated with infective endocarditis (IE) on native or prosthetic valve by 68Ga-DOTATOC PET/CT.
Time frame: one year
To quantify the infective foci uptake of 68Ga-DOTATOC with measure of Standard Uptake Value (SUV) related to blood activity.
Time frame: one year
To compare 68Ga-DOTATOC PET/CT results with 18F-FDG PET/CT results, of visual and quantitative analysis on whole body PET/CT
Time frame: one year
Central Hospital, Nancy, France
Other
Early Feasibility Study of Somatostatin Receptors PET Imaging (68Ga-DOTATOC PET/CT) for the Diagnosis of Infective Endocarditis
Acronym: DOTENDO
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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