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

NCT05183555 | Completed Phase 2

• 1 other identifier: 2021PI119
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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

Conditions

Infective Endocarditis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• To quantify the infective foci uptake of 68Ga-DOTATOC

  one year

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

  one year

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

  one year

Study Arms (1)

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.

Drug: 68Ga-DOTATOC PET/CT

Interventions

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

Also known as: 18F-FDG PET/CT

Patients with definite IE will be included and referred for 18F-FDG PET/CT in the study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHRU de NANCY

Vandœuvre-lès-Nancy, 54511, France

Location

MeSH Terms

Conditions

Endocarditis

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: January 10, 2022
• Study Start: May 16, 2022
• Primary Completion: June 18, 2024
• Study Completion: June 18, 2024
• Last Updated: September 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)