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

NCT ID: NCT03347760

Last Updated: 2024-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-13
• Study Completion Date: 2023-12-13

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

Conditions

Myocarditis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Experimental arm

All included patients wil receive 68Ga-dotatoc-PET/CT suspected acute myocarditis in first and an other 68Ga-dotatoc-PET/CT 6 months later

Group Type: EXPERIMENTAL

DOTATOC-68Ga PET initial

Intervention Type: DRUG

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

DOTATOC-68Ga PET at 6 months

Intervention Type: DRUG

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

blood sample

Intervention Type: BIOLOGICAL

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

blood sample

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

Intervention Type: BIOLOGICAL

Other Intervention Names

Imaging PET/CT; Imaging PET/CT

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central Hospital, Nancy, France

OTHER

Sponsor Role: lead

Responsible Party

Elodie CHEVALIER

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elodie CHEVALIER, MD

Role: PRINCIPAL_INVESTIGATOR

CHRU de NANCY

Locations

Véronique ROCH

Vandœuvre-lès-Nancy, , France

Countries

France

References

Larive T, Boursier C, Claudin M, Varlot J, Filippetti L, Huttin O, Roch V, Imbert L, Doyen M, Fraix A, Mandry D, Chevalier E, Marie PY. Persistent somatostatin PET signs of inflammatory cells 4 to 5 months after acute myocarditis are linked to a poorer recovery of cardiac function. Eur J Nucl Med Mol Imaging. 2025 Jul;52(9):3395-3403. doi: 10.1007/s00259-025-07202-5. Epub 2025 Mar 22.

Reference Type: DERIVED

PMID: 40119896 (View on PubMed)

Other Identifiers

2019-002716-43

Identifier Type: -

Identifier Source: org_study_id