Skip to main content
OpenTrials
Completed

NCT Number: NCT05183555

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHRU de NANCY

Vandœuvre-lès-Nancy, 54511, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

68Ga-DOTATOC PET/CT

Drug

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

Primary outcomes

  1. Detectability of infective endocarditis by 68Ga-DOTATOC 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.

Secondary outcomes

  1. To quantify the infective foci uptake of 68Ga-DOTATOC

    Time frame: one year

    To quantify the infective foci uptake of 68Ga-DOTATOC with measure of Standard Uptake Value (SUV) related to blood activity.

  2. 68Ga-DOTATOC PET/CT and 18F-FDG PET/CT results comparison

    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

  3. 68Ga-DOTATOC PET/CT and 18F-FDG PET/CT results comparison of cardiac step

    Time frame: one year

    • To compare the 68Ga-DOTATOC PET/CT results with those of 18F-FDG PET/CT, of visual and quantitative analysis of cardiac step recordings

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Acronym: DOTENDO

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 10, 2022
Registry last updated
Sep 26, 2024

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.

Published trials that share one or more normalized conditions with this study.