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Pilot Study Evaluating Somatostatin Receptor's PET Imaging to Detect Inflammatory Phases of Myocarditis

NCT03347760 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2024-02-09

No results posted yet for this study

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

Conditions

Interventions

DRUG

DOTATOC-68Ga PET initial

DOTATOC is a tracer of high affinity for the type 2 somatostatin receptors and is used for imaging of tumours which are expressing them, including endocrine tumours

DRUG

DOTATOC-68Ga PET at 6 months

DOTATOC is a tracer of high affinity for the type 2 somatostatin receptors and is used for imaging of tumours which are expressing them, including endocrine tumours

BIOLOGICAL

blood sample

blood tests will be carried out during the control visit to ensure that biological parameters are normalized

Sponsors & Collaborators

  • Central Hospital, Nancy, France

    lead OTHER

Principal Investigators

  • Elodie CHEVALIER, MD · CHRU de NANCY

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-13
Primary Completion
2023-07-30
Completion
2023-12-13

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03347760 on ClinicalTrials.gov