A Phase 2 interventional study of 68Ga-DOTATOC PET/CT in Infective Endocarditis, sponsored by Central Hospital, Nancy, France. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-26.
Sponsored by Central Hospital, Nancy, France · Phase 2, Interventional, and Diagnostic
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
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.
173 studies on the registry are indexed under Endocarditis; 57 are open to participants now.
This study's enrollment of 14 is below the median of 92 across 86 interventional studies indexed under Endocarditis.
Browse Endocarditis studies →Central Hospital, Nancy, France is the lead sponsor of 798 studies on the registry; 186 are open to participants now.
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Fourteen patients with definite IE according to the modified Duke criteria (Li) will be included and referred for 18F-FDG PET/CT in the study. A 68Ga-DOTATOC PET/CT scan will be performed specifically for research at 24 hours.
Drug: 68Ga-DOTATOC PET/CT
68Ga-DOTATOC PET/CT will be recorded the following day of 18F-FDG PET/CT if patient signed the consent
Also known as: 18F-FDG PET/CT
Detectability of infective endocarditis by 68Ga-DOTATOC PET/CT
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
To quantify the infective foci uptake of 68Ga-DOTATOC with measure of Standard Uptake Value (SUV) related to blood activity.
Time frame: one year
68Ga-DOTATOC PET/CT and 18F-FDG PET/CT results comparison
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
68Ga-DOTATOC PET/CT and 18F-FDG PET/CT results comparison of cardiac step
3. To compare the 68Ga-DOTATOC PET/CT results with those of 18F-FDG PET/CT, of visual and quantitative analysis of cardiac step recordings
Time frame: one year
Plan to share: No
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Ran from May 2022 to primary completion in Jun 2024, 25 months.
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This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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