Clinical trial • Phase II • Other

Gallium citrate Ga-68 for Prosthetic valve infective endocarditis

Phase II trial of Gallium citrate Ga-68 for Prosthetic valve infective endocarditis.

Overview

Trial Therapeutic Area
Other
Trial Disease
Prosthetic valve infective endocarditis
Trial Stage
Phase II
Drug Modality
Radiopharmaceutical

Key dates

Initial CTIS Submission Date
14-06-2024
First CTIS Authorization Date
04-07-2024

Trial design

18FDG-PET/CT (standard management imaging comparator; all patients will have 18FDG-PET/CT as part of standard management in addition to the 68Ga-PET/CT used for the research)-controlled Phase II trial across 1 site in France.

Comparator
18FDG-PET/CT (standard management imaging comparator; all patients will have 18FDG-PET/CT as part of standard management in addition to the 68Ga-PET/CT used for the research)
Target Sample Size
40

Eligibility

Recruits 40 Excludes "persons deprived of liberty by judicial or administrative decision, minors, adults subject to a legal protection measure or unable to express their consent"; requires "Free, informed and written consent signed by the participant and the investigator"..

Pregnancy Exclusion
pregnant or breastfeeding women
Vulnerable Population
Excludes "persons deprived of liberty by judicial or administrative decision, minors, adults subject to a legal protection measure or unable to express their consent"; requires "Free, informed and written consent signed by the participant and the investigator".

Inclusion criteria

  • {"criterion_text":"- Adult patient (over 18 years old)"}
  • {"criterion_text":"- Patient with a prosthetic heart valve"}
  • {"criterion_text":"- Patient suspected of infective endocarditis (on clinical and/or microbiological and/or imaging data)"}
  • {"criterion_text":"- Patient whose history is discussed in the multidisciplinary meeting dedicated to endocarditis"}
  • {"criterion_text":"- Patient beneficiary of a social security scheme"}
  • {"criterion_text":"- Free, informed and written consent signed by the participant and the investigator"}

Exclusion criteria

  • {"criterion_text":"- pregnant or breastfeeding women"}
  • {"criterion_text":"- women of childbearing potential not using effective contraception"}
  • {"criterion_text":"- patients referred to in articles L.1121-5 to L.1121-8 (persons deprived of liberty by judicial or administrative decision, minors, adults subject to a legal protection measure or unable to express their consent)"}
  • {"criterion_text":"- Patient with cardiac surgery within 2 months of inclusion"}
  • {"criterion_text":"- Subject in a period of relative exclusion due to another protocol"}
  • {"criterion_text":"- Known contraindication to PET/CT with injection of radiotracers (hypersensitivity to radiopharmaceuticals and/or excipients)"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Sensitivity of 68Ga-PET/CT for the diagnosis of prosthetic valve infective endocarditis in patients suspected of infective endocarditis on prosthetic valve","definition_or_measurement_approach":"Estimation of sensitivity of 68Ga-PET/CT for the diagnosis of prosthetic valve infective endocarditis in the target population (methodology/details not further specified in the record)"}

Secondary endpoints

  • {"endpoint_text":"- Specificity, positive and negative predictive values of 68Ga-PET/CT for the diagnosis of infective endocarditis on prosthetic valve in patients suspected of infective endocarditis on prosthetic valve","definition_or_measurement_approach":"Estimation of specificity, positive and negative predictive values of 68Ga-PET/CT (detailed measurement approach not specified)"}
  • {"endpoint_text":"- Cohen's kappa for inter-observer reproducibility of 68Ga-PET/CT for the diagnosis of infective endocarditis on prosthetic valve in patients suspected of infective endocarditis on prosthetic valve","definition_or_measurement_approach":"Inter-observer reproducibility measured by Cohen's kappa"}
  • {"endpoint_text":"- Sensitivity, specificity and positive and negative predictive values of 18FDG-PET/CT for the diagnosis of infective endocarditis on prosthetic valve","definition_or_measurement_approach":"Estimation of diagnostic accuracy parameters for 18FDG-PET/CT (measurement details not specified)"}
  • {"endpoint_text":"- Discrepancies between 68Ga-PET/CT and 18FDG-PET/CT for the evaluation of the spread of infection assessment and the search for the initial portal of pathogen entry","definition_or_measurement_approach":"Assessment of discordances between the two imaging modalities (detailed criteria not specified)"}

Recruitment

Planned Sample Size
40
Recruitment Window Months
24
Consent Approach
Free, informed and written consent signed by the participant and the investigator ("Free, informed and written consent signed by the participant and the investigator"). Minors and those unable to express consent are excluded.

Geography

Total Number Of Sites
1
Total Number Of Participants
40

France

Earliest CTIS Part Ii Submission Date
20-06-2024
Latest Decision Or Authorization Date
04-07-2024
Processing Time Days
14
Number Of Sites
1
Number Of Participants
40

Sites

Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Service de Médecine Interne et Maladies Infectieuses
Principal Investigator Name
Carine GREIB
Principal Investigator Email
carine.greib@chu-bordeaux.fr
Contact Person Name
Carine GREIB
Contact Person Email
carine.greib@chu-bordeaux.fr

Sponsor

Primary sponsor

Full Name
Centre Hospitalier Universitaire De Bordeaux
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
France

Investigational products

Investigational Product Name
68 Gallium citrate
Active Substance
Gallium citrate Ga-68
Modality
Radiopharmaceutical
Routes Of Administration
SOLUTION FOR INJECTION
Route
SOLUTION FOR INJECTION
Authorisation Status
prodAuthStatus: 1
Maximum Dose
150 MBq

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