Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05183555
Other study ID # 2021PI119
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date April 2022
Est. completion date January 2024

Study information

Verified date December 2021
Source Central Hospital, Nancy, France
Contact Caroline BOURSIER, MD
Phone 383154039
Email c.boursier@chru-nancy.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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 hypoglucidic-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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 14
Est. completion date January 2024
Est. primary completion date March 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Central Hospital, Nancy, France

Outcome

Type Measure Description Time frame Safety issue
Primary 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. one year
Secondary 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. one year
Secondary 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 one year
Secondary 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 one year
See also
  Status Clinical Trial Phase
Recruiting NCT05862025 - Evaluation of the Usefulness of Echocardiography in Patients With Staphylococcus Aureus Bacteremia (ET-AUREUS Study). N/A
Completed NCT03590106 - Cardiac Surgery Peer Recovery Support Program N/A
Not yet recruiting NCT05563662 - SURgical Registry of ENDocarditis EuRope
Completed NCT00947817 - Impact of Endothelial Cell Activation and Modifications of Haemostasis Induced by Infective Endocarditis on the Risk of Embolism N/A
Recruiting NCT00624091 - Rationale, Design and Methods for the Early Surgery in Infective Endocarditis Study (ENDOVAL) Phase 4
Terminated NCT00695903 - Phase 2 Study of Safety, Efficacy, and Pharmacokinetics of Higher Doses of Daptomycin and Vancomycin in MRSA Bacteremia Phase 2
Recruiting NCT04992923 - Prospective Cohort Study of Patients With Infective Endocarditis at Pitié-Salpêtrière Hospital
Recruiting NCT03642379 - Cardiac Surgery Peer Support Recovery N/A
Recruiting NCT05264181 - Transcatheter Pulmonary Valve Implantation With SAPIEN 3 Valve
Recruiting NCT04257292 - NExt-Generation Sequencing and Cell Culture-based Characterization of S. Aureus in Infective Endocarditis
Active, not recruiting NCT03683355 - Characterization of RadiOlabeled Tracer Uptake Pattern in Noninfected Transcatheter Aortic Valves.
Not yet recruiting NCT00550823 - Cardiac Computarized Tomography in Infective Endocarditis N/A
Not yet recruiting NCT00562653 - Autoantibodies and Clinical Symptoms in Infective Endocarditis Patients N/A
Completed NCT03153384 - Impact of the Blood Culture Technique on the Diagnosis of Infective Endocarditis
Not yet recruiting NCT06194409 - The Incidence, Clinical Characteristics and Outcome of Infective Endocarditis Among Intravenous Drug Abusers Versus Non-Drug Abusers.
Completed NCT03945708 - Does Whole Blood Adsorber During CPB Reduce Vasoactive Drugs Postoperatively in Endocarditis Patients Undergoing Valve Surgery? N/A
Not yet recruiting NCT06269679 - CBCT vs OPT on the Oral Health Status at 12 Months of Patients Hospitalized for Infective Endocarditis. N/A
Recruiting NCT03626571 - PET/MR Imaging In Patients With Infective Endocarditis
Completed NCT03612245 - Hygiene and Bucco-dental Status of Patients With Oral Streptococcal Endocarditis
Completed NCT02910856 - Infective Endocarditis in the Elderly