Infective EndocarditisPhase 2DOTENDONCT05183555
Early Feasibility Study of Somatostatin Receptors PET Imaging for the Diagnosis of Infective Endocarditis
A Phase 2 study testing 68Ga-DOTATOC PET/CT in people with Infective Endocarditis, run by Central Hospital, Nancy, France at 1 site in France.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infective Endocarditis
- What is being tested?
- 68Ga-DOTATOC PET/CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- 16 May 2022to 18 Jun 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Feasibility Study of Somatostatin Receptors PET Imaging (68Ga-DOTATOC PET/CT) 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
Read the 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.
- Conditions
- Infective Endocarditis
- Being tested
- 68Ga-DOTATOC PET/CT
- Medical subject headings
- Endocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-DOTATOC PET/CTDrug
Also called 18F-FDG PET/CT
68Ga-DOTATOC PET/CT will be recorded the following day of 18F-FDG PET/CT if patient signed the consent
| Study group | Role | What they receive |
|---|---|---|
| Patients with definite IE will be included and referred for 18F-FDG PET/CT in the study | Experimental | 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. Receives: Drug: 68Ga-DOTATOC PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Secondary outcomes (3)
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.
Measured: 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
Measured: one year
68Ga-DOTATOC PET/CT and 18F-FDG PET/CT results comparison of cardiac step
- To compare the 68Ga-DOTATOC PET/CT results with those of 18F-FDG PET/CT, of visual and quantitative analysis of cardiac step recordings
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start16 May 2022
- Primary completion18 Jun 2024
- Study completion18 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infective EndocarditisStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BOURSIER Caroline, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05183555
- Sponsor's protocol ID
- 2021PI119
- Acronym
- DOTENDO
- Status last verified
- Sep 2024
- First submitted
- 21 Dec 2021
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Feasibility Study of Somatostatin Receptors PET Imaging (68Ga-DOTATOC PET/CT) for the Diagnosis of Infective Endocarditis
- ClinicalTrials.gov ID
- NCT05183555
- Acronym / sponsor ID
- DOTENDO / 2021PI119
- Conditions
- Infective Endocarditis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 16 May 2022 (actual)
- Primary completion
- 18 Jun 2024 (actual)
- Study completion
- 18 Jun 2024 (actual)
- First posted
- 10 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Patients with definite IE will be included and referred for 18F-FDG PET/CT in the study | Experimental | Drug: 68Ga-DOTATOC PET/CTFourteen 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-DOTATOC PET/CTAlso: 18F-FDG PET/CT68Ga-DOTATOC PET/CT will be recorded the following day of 18F-FDG PET/CT if patient signed the consent | Drug | Patients with definite IE will be included and referred for 18F-FDG PET/CT in the study |
Primary outcome
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.
3 secondary outcomes
To quantify the infective foci uptake of 68Ga-DOTATOC
Time frame: one year
68Ga-DOTATOC PET/CT and 18F-FDG PET/CT results comparison
Time frame: one year
68Ga-DOTATOC PET/CT and 18F-FDG PET/CT results comparison of cardiac step
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 68Ga-DOTATOC PET/CT in people with Infective Endocarditis, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detectability of infective endocarditis by 68Ga-DOTATOC PET/CT (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024; AzTrials last refreshed its copy on 8 Nov 2026.