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

Primary Purpose

Myocarditis

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
DOTATOC-68Ga PET initial
DOTATOC-68Ga PET at 6 months
blood sample
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Myocarditis focused on measuring 68-Ga-DOTATOC PET, Myocarditis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Véronique ROCHRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental arm

Arm Description

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

Outcomes

Primary Outcome Measures

Presence of a significant myocardial retention of 68Ga-DOTATOC during initial staging. Sensibility calculation
The criterion of positivity will be that of a visually detectable and quantitatively significant area of myocardial uptake, which will be defined by a measurement of the Standardized Uptake Value (SUV) at least 30% higher than that of the blood signal obtained at the center of the left ventricular cavity. This threshold was chosen based on measurements already published in a small pilot study.

Secondary Outcome Measures

Frequency of a significant myocardial retention of 68Ga-DOTATOC during initial staging
a visually detectable and quantitatively significant area of myocardial uptake, which will be defined by a measurement of the Standardized Uptake Value (SUV) at least 30% higher than that of the blood signal obtained at the center of the left ventricular cavity. This threshold was chosen based on measurements already published in a small pilot study. a visually detectable and quantitatively significant area of myocardial uptake, which will be defined by a measurement of the Standardized Uptake Value (SUV) at least 30% higher than that of the blood signal obtained at the center of the left ventricular cavity. This threshold was chosen based on measurements already published in a small pilot study. visually detectable and quantitatively significant area of myocardial uptake, which will be defined by a measurement of the Standardized Uptake Value (SUV) at least 30% higher than that of the blood signal obtained at the center of the left ventricular cavity.

Full Information

First Posted
November 16, 2017
Last Updated
August 3, 2021
Sponsor
Central Hospital, Nancy, France
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1. Study Identification

Unique Protocol Identification Number
NCT03347760
Brief Title
Pilot Study Evaluating Somatostatin Receptor's PET Imaging to Detect Inflammatory Phases of Myocarditis
Acronym
DOTAMIR
Official Title
Monocentric Interventionnal Pilot Study Pilot Study Evaluating Somatostatin Receptor's PET Imaging to Detect Inflammatory Phases of Myocarditis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Recruiting
Study Start Date
July 13, 2020 (Actual)
Primary Completion Date
July 30, 2021 (Actual)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Hospital, Nancy, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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: this radiopharmaceutical is enough sensitive to detect most of the acute inflammatory myocarditis which are identified by the MRI and 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocarditis
Keywords
68-Ga-DOTATOC PET, Myocarditis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental arm
Arm Type
Experimental
Arm Description
All included patients wil receive 68Ga-dotatoc-PET/CT suspected acute myocarditis in first and an other 68Ga-dotatoc-PET/CT 6 months later
Intervention Type
Drug
Intervention Name(s)
DOTATOC-68Ga PET initial
Other Intervention Name(s)
Imaging PET/CT
Intervention Description
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
Intervention Name(s)
DOTATOC-68Ga PET at 6 months
Other Intervention Name(s)
Imaging PET/CT
Intervention Description
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
Biological
Intervention Name(s)
blood sample
Intervention Description
blood tests will be carried out during the control visit to ensure that biological parameters are normalized
Primary Outcome Measure Information:
Title
Presence of a significant myocardial retention of 68Ga-DOTATOC during initial staging. Sensibility calculation
Description
The criterion of positivity will be that of a visually detectable and quantitatively significant area of myocardial uptake, which will be defined by a measurement of the Standardized Uptake Value (SUV) at least 30% higher than that of the blood signal obtained at the center of the left ventricular cavity. This threshold was chosen based on measurements already published in a small pilot study.
Time Frame
at baseline
Secondary Outcome Measure Information:
Title
Frequency of a significant myocardial retention of 68Ga-DOTATOC during initial staging
Description
a visually detectable and quantitatively significant area of myocardial uptake, which will be defined by a measurement of the Standardized Uptake Value (SUV) at least 30% higher than that of the blood signal obtained at the center of the left ventricular cavity. This threshold was chosen based on measurements already published in a small pilot study. a visually detectable and quantitatively significant area of myocardial uptake, which will be defined by a measurement of the Standardized Uptake Value (SUV) at least 30% higher than that of the blood signal obtained at the center of the left ventricular cavity. This threshold was chosen based on measurements already published in a small pilot study. visually detectable and quantitatively significant area of myocardial uptake, which will be defined by a measurement of the Standardized Uptake Value (SUV) at least 30% higher than that of the blood signal obtained at the center of the left ventricular cavity.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elodie CHEVALIER, MD
Phone
03.83.15.74.02
Ext
+33
Email
e.chevalier@chru-nancy.fr
First Name & Middle Initial & Last Name or Official Title & Degree
MARIE Pierre-Yves, MD-PhD
Phone
03 83 15 39 09
Ext
+33
Email
py.marie@chru-nancy.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elodie CHEVALIER, MD
Organizational Affiliation
CHRU de NANCY
Official's Role
Principal Investigator
Facility Information:
Facility Name
Véronique ROCH
City
Vandoeuvre/les/nancy
ZIP/Postal Code
54511
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Véronique ROCH, MSc
Phone
+33383154276
Email
v.roch@chru-nancy.fr

12. IPD Sharing Statement

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

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