Clinical trial NCT03347760: Pilot Study Evaluating Somatostatin Receptor's PET Imaging to Detect Inflammatory Phases of Myocarditis
Official title: Monocentric Interventionnal Pilot Study Pilot Study Evaluating Somatostatin Receptor's PET Imaging to Detect Inflammatory Phases of Myocarditis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocarditis
Keywords: 68-Ga-DOTATOC PET
Myocarditis
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2017-11-20
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Infectious myocarditis are frequent, most of the time viral and can evolve to cardiac insufficiency. The diagnosis is difficult because they can mime an acute coronary syndrome. Approximately 10 % of patients with acute infarction suspected, have a normal angiography, and half of them has in fact a myocarditis, as showed studies of cardiac MRI among which some realized in our department . However, anomalies observed in MRI are not specific and it is necessary to use multiple criterions. A new radiopharmaceutical, the 68Ga-DOTATOC, specific of somatostatin's receptors which are over expressed by the inflammatory cells, has recently showed the capacity to identify myocarditis, but only in a small group of 6 patients.

The investigators make assumptions:

1. this radiopharmaceutical is enough sensitive to detect most of the acute inflammatory myocarditis which are identified by the MRI and
2. it could maybe allow to identify myocarditis with a persistent subacute or chronic inflammation, which are difficult to identify with cardiac MRI, and it would be a new information able to guide the medical decision.

Primary objectif: to determine if PET with 68Ga-DOTATOC is enough sensitive to identify myocarditis in acute inflammatory phase by hospitalized patients with suspected acute infarction and with normal angiography and who have a high probability of myocarditis identified by MRI. Disease prevalence will be close to 100 % at baseline Secondary objectives: 1. Estimate the frequency of inflammatory forms (subacute or chronicle), with a 68Ga-DOTATOC PET at 3 to 5 months from baseline, when classic signs of acute inflammatory generally disappeared (CRP, Troponin-I, myocardial oedema in MRI).

2. Analyze the concordance of the results of 68Ga-DOTATOC TEP by two readers


Eligibility criteria: Inclusion Criteria:

* Adult subjects who have given their written consent to participate in the study.
* Patients without history of heart disease, hospitalized for acute infarction suspected with positive troponine, normal or subnormal angiography and which have a high probability of acute inflammatory myocardities on the secondarily realized MRI (= 2 criteria of Lake Louise)
* No contraindication to perform a 68Ga-DOTATOC-PET .
* Patient belong to a social security scheme.

Exclusion Criteria:

* Patients under guardianship or curatorship.
* Pregnancy, breastfeeding and woman of childbearing age without effective contraception
* Impossibility to perform a PET with 68Ga-DOTATOC (patient agitated).
* Impossibility to schedule PET/CT before the deadline = in 7 days since the beginning of the hospitalization.

Primary outcomes:
measure: Presence of a significant myocardial retention of 68Ga-DOTATOC during initial staging. Sensibility calculation
timeFrame: at baseline
Secondary outcomes:
measure: Frequency of a significant myocardial retention of 68Ga-DOTATOC during initial staging
timeFrame: 6 months
Other outcomes:
Locations:
city: Vandoeuvre/les/nancy
country: France
facility: Véronique ROCH
Study officials:
affiliation: CHRU de NANCY
name: Elodie CHEVALIER, MD
role: PRINCIPAL_INVESTIGATOR
References: