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Early Feasibility Study of Somatostatin Receptors PET Imaging for the Diagnosis of Infective Endocarditis

Early Feasibility Study of Somatostatin Receptors PET Imaging (68Ga-DOTATOC PET/CT) for the Diagnosis of Infective Endocarditis

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05183555
Acronym
DOTENDO
Enrollment
14
Registered
2022-01-10
Start date
2022-05-16
Completion date
2024-06-18
Last updated
2024-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infective Endocarditis

Brief summary

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

Detailed description

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.

Interventions

68Ga-DOTATOC PET/CT will be recorded the following day of 18F-FDG PET/CT if patient signed the consent

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

Single-center, early feasibility clinical trial (RIPH1 type) using a radiopharmaceutical (drug) off-label. This study is based on the evaluation of an off-label radiopharmaceutical, 68Ga-DOTATOC in PET/CT, to detect infective endocarditis. The marketing authorization of 68Ga-DOTATOC is for the neuroendocrine tumors assessment (NET). Currently, a clinical study using 68Ga-DOTATOC PET/CT to detect myocarditis in the inflammatory phase is conducted by a team of the CHRU of Nancy 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adult who has received full information about the organisation of the research and has signed informed consent adult * Participant hospitalised for definite AE according to modified Duke criteria (Li), on native or prosthetic valve, referred for 18F-FDG PET/CT from Cardiology and Infectious Diseases departments

Exclusion criteria

* Person with a history of hypersensitivity from previous use of 68Ga-DOTATOC * Unable to perform a 68Ga-DOTATOC PET scan (agitated, confused patient...). * Inability to schedule 68Ga-DOTATOC PET/CT the day after 18F-FDG PET/CT. * Person with severe renal impairment (GFR \<30 ml/min/1.73 m2) * Participant treated with a somatostatin analogue. * Participant with Cushing's syndrome * Pregnant, potentially pregnant or breastfeeding women * Adult subject to a legal protection measure (guardianship, curatorship, safeguard of justice) * Person of full age who is unable to give consent * Person deprived of liberty by a judicial or administrative decision * Person subject to psychiatric care by virtue of Articles L. 3212-1 and L. 3213-1

Design outcomes

Primary

MeasureTime frameDescription
Detectability of infective endocarditis by 68Ga-DOTATOC PET/CTone yearto visually evaluate the detectability of cardiac and extracardiac foci associated with infective endocarditis (IE) on native or prosthetic valve by 68Ga-DOTATOC PET/CT.

Secondary

MeasureTime frameDescription
To quantify the infective foci uptake of 68Ga-DOTATOCone yearTo quantify the infective foci uptake of 68Ga-DOTATOC with measure of Standard Uptake Value (SUV) related to blood activity.
68Ga-DOTATOC PET/CT and 18F-FDG PET/CT results comparisonone yearTo compare 68Ga-DOTATOC PET/CT results with 18F-FDG PET/CT results, of visual and quantitative analysis on whole body PET/CT
68Ga-DOTATOC PET/CT and 18F-FDG PET/CT results comparison of cardiac stepone year3\. To compare the 68Ga-DOTATOC PET/CT results with those of 18F-FDG PET/CT, of visual and quantitative analysis of cardiac step recordings

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026