Assessment of PET for detection of infectious myocarditis

Phase 1

• Conditions: infectious myocarditis; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2019-002716-43-FR
• Lead Sponsor: CHRU DE NANCY

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-31
• Last Update Posted: 22 June 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

- Major patient having received complete information on the organization of the research and having signed their informed consent.
- Patient hospitalized for chest pain with positive troponins,
- Patient with a high probability of acute inflammatory myocarditis on secondary MRI (= 2 Lake Louise criteria)
- Person affiliated with or benefiting from a social security scheme.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

- Patient with history of heart disease
- Patient with coronary stenosis of more than 50% on coronary angiography or CT
- Patient with a formal or relative contraindication for performing a PET / CT scan at 68Ga DOTATOC
- Impossibility of performing a PET scan at 68Ga-DOTATOC (agitated, confused patient ...). Unable to schedule the PET / CT exam at 68Ga-DOTATOC within a maximum of 72 hours after the MRI.
- Patient currently being treated with corticosteroids prior to the 68Ga-DOTATOC PET / CT examination.
- Patient treated with a somatostatin analogue.
- Patient with Cushing's syndrome
- Pregnant woman, likely to be pregnant or breastfeeding
- A person of full age who is the subject of a legal protection measure (guardianship, curatorship, safeguard of justice)
- A person of full age who is unable to express their consent
- Person deprived of their liberty by a judicial or administrative decision
- Person undergoing psychiatric care under Articles L. 3212-1 and L. 3213-1

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified