MyocarditisDOTAMIRNCT03347760
Pilot Study Evaluating Somatostatin Receptor's PET Imaging to Detect Inflammatory Phases of Myocarditis
A study testing DOTATOC-68Ga PET initial, DOTATOC-68Ga PET at 6 months and blood sample in people with Myocarditis, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocarditis
- What is being tested?
- DOTATOC-68Ga PET initial, DOTATOC-68Ga PET at 6 months and blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jul 2020to 13 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Monocentric Interventionnal Pilot Study Pilot Study Evaluating Somatostatin Receptor's PET Imaging to Detect Inflammatory Phases of Myocarditis
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:
Read more
- 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).
- Analyze the concordance of the results of 68Ga-DOTATOC TEP by two readers
- Conditions
- Myocarditis
- Being tested
- DOTATOC-68Ga PET initial, DOTATOC-68Ga PET at 6 months, blood sample
- Keywords
- 68-Ga-DOTATOC PET, Myocarditis
- Medical subject headings
- Myocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DOTATOC-68Ga PET initialDrug
Also called Imaging PET/CT
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 monthsDrug
Also called Imaging PET/CT
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 sampleBiological
blood tests will be carried out during the control visit to ensure that biological parameters are normalized
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | All included patients wil receive 68Ga-dotatoc-PET/CT suspected acute myocarditis in first and an other 68Ga-dotatoc-PET/CT 6 months later Receives: Drug: DOTATOC-68Ga PET initial; Drug: DOTATOC-68Ga PET at 6 months; Biological: blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at baseline
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study start13 Jul 2020
- Primary completion30 Jul 2023
- Study completion13 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MyocarditisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elodie CHEVALIER, Central Hospital, Nancy, France
- Investigators
- Elodie CHEVALIER, MD, Principal investigator, CHRU de NANCY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03347760
- Sponsor's protocol ID
- 2019-002716-43
- Other IDs
- 2019
- Acronym
- DOTAMIR
- Status last verified
- Jun 2026
- First submitted
- 16 Nov 2017
- Last updated
- 25 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Larive T, Boursier C, Claudin M, Varlot J, Filippetti L, Huttin O, Roch V, Imbert L, Doyen M, Lambert A, Mandry D, Lamiral Z, Chevalier E, Marie PY. Factors Associated with Myocardial Uptake on Oncologic Somatostatin PET Investigations and Differentiation from Myocardial Uptake of Acute Myocarditis. J Nucl Med. 2024 Aug 1;65(8):1279-1285. doi: 10.2967/jnumed.123.267219.
PubMed 38991751Larive 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.
PubMed 40119896
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monocentric Interventionnal Pilot Study Pilot Study Evaluating Somatostatin Receptor's PET Imaging to Detect Inflammatory Phases of Myocarditis
- ClinicalTrials.gov ID
- NCT03347760
- Acronym / sponsor ID
- DOTAMIR / 2019-002716-43
- Conditions
- Myocarditis
- Keywords
- 68-Ga-DOTATOC PET, Myocarditis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 13 Jul 2020 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 13 Dec 2023 (actual)
- First posted
- 20 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
- Analyze the concordance of the results of 68Ga-DOTATOC TEP by two readers
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Drug: DOTATOC-68Ga PET initial, Drug: DOTATOC-68Ga PET at 6 months, Biological: blood sampleAll included patients wil receive 68Ga-dotatoc-PET/CT suspected acute myocarditis in first and an other 68Ga-dotatoc-PET/CT 6 months later |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DOTATOC-68Ga PET initialAlso: Imaging PET/CTDOTATOC 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 | Experimental arm |
| DOTATOC-68Ga PET at 6 monthsAlso: Imaging PET/CTDOTATOC 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 | Experimental arm |
| blood sampleblood tests will be carried out during the control visit to ensure that biological parameters are normalized | Biological | Experimental arm |
Primary outcome
Presence of a significant myocardial retention of 68Ga-DOTATOC during initial staging. Sensibility calculation
Time frame: at baseline
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.
1 secondary outcome
Frequency of a significant myocardial retention of 68Ga-DOTATOC during initial staging
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Results publication: PubMed 38991751Larive T, Boursier C, Claudin M, Varlot J, Filippetti L, Huttin O, Roch V, Imbert L, Doyen M, Lambert A, Mandry D, Lamiral Z, Chevalier E, Marie PY. Factors Associated with Myocardial Uptake on Oncologic Somatostatin PET Investigations and Differentiation from Myocardial Uptake of Acute Myocarditis. J Nucl Med. 2024 Aug 1;65(8):1279-1285. doi: 10.2967/jnumed.123.267219.
- Results publication: PubMed 40119896Larive 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elodie CHEVALIER, MD principal investigator
CHRU de NANCY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DOTATOC-68Ga PET initial, DOTATOC-68Ga PET at 6 months and blood sample in people with Myocarditis, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of a significant myocardial retention of 68Ga-DOTATOC during initial staging. Sensibility calculation (time frame: at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03347760, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.