Cardiac SarcoidosisCuDOSISNCT06131112
Macrophage PET/CT Imaging Using 64Cu-DOTATATE for the Diagnosis of Cardiac Sarcoidosis
An observational study of Cardiac Sarcoidosis, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The purpose of the CuDOSIS study is to examine the diagnostic value of activated macrophage imaging in patients with or under evaluation for cardiac sarcoidosis. The PET/CT tracer 64Cu-DOTATATE is used as a tool to identify activated macrophages. The trial is an open-label prospective study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Sarcoidosis
- What is being tested?
- 64Cu-DOTATATE PET/CT scan
- How many people
- 76 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2023to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: The study will include adults (18 years or older) from the Department of Cardiology and Department of Clinical Physiology, Nuclear Medicine, and PET at Rigshospitalet. The study will include a total of 76 participants: 54 patients from groups A-C and data from 22 patients from group D.
Who may be able to join
- Age => 18 years
- Group A: 22 patients with clinically suspected cardiac sarcoidosis Group B: 22 patients with known cardiac sarcoidosis Group C: Up to 10 patients with clinically suspected or confirmed acute lymphocytic myocarditis Group D: 22 patients with NET without known inflammatory heart disease who have previously been scanned with 64Cu-DOTATATE PET/CT as part of their routine diagnostic work-up or follow-up (control group)
Who cannot join
- Severe obesity (weight > 140 kg)
- Pregnancy (negative point-of-care urine/serum human chorion gonadotropin is required in all fertile women)
- Severe claustrophobia
- Known allergy to 64Cu-DOTATATE
- Clinically critical condition which makes PET/CT impossible
- Diabetes with insulin dependence
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet
Copenhagen
Finn Gustafsson, MD,PhD,DMSc, +45 35456340, finn.gustafsson@regionh.dk
Adelina Yafasova, MD, +45 35456252, adelina.henney.yafasova@regionh.dk
About this study
Official title: Macrophage PET/CT Imaging for the Diagnosis of Cardiac Sarcoidosis
The purpose of the CuDOSIS study is to examine the diagnostic value of activated macrophage imaging in patients with or under evaluation for cardiac sarcoidosis. The PET/CT tracer 64Cu-DOTATATE is used as a tool to identify activated macrophages. The trial is an open-label prospective study. The study will include 54 participants from the Department of Cardiology and the Department of Clinical Physiology, Nuclear Medicine, and PET at Rigshospitalet. Further, the study will include data from 22 patients with NET who have been scanned with 64Cu-DOTATATE PET/CT previously as negative controls.
Participants will be included in the following groups:
Group A: 22 patients with clinically suspected cardiac sarcoidosis Group B: 22 patients with known cardiac sarcoidosis Group C: Up to 10 patients with clinically suspected or confirmed acute lymphocytic myocarditis Group D: 22 patients with NET without known inflammatory heart disease who have previously been scanned with 64Cu-DOTATATE PET/CT as part of their routine diagnostic work-up or follow-up (control group)
Read the detailed description
Cardiac involvement is considered a serious condition and a frequent cause of death in patients with sarcoidosis. 18F-FDG PET/CT is currently used as part of the diagnostic criteria for cardiac sarcoidosis, but it has shown limitations in the evaluation of cardiac sarcoidosis due to the high physiological uptake of FDG in normal cardiac muscle. Elaborate preparations are required for patients including either a low-carbohydrate diet followed by long fasting or heparin loading before FDG-PET. In heparin loading, the rare adverse effect of heparin-induced thrombocytopenia should be considered. Therefore, it is of interest to find a PET/CT tracer that displays high sensitivity and specificity without requiring thorough patient preparation and minimizing any adverse effects.
A potential tracer is the somatostatin-based tracer 64Cu-DOTATATE, which is routinely used for the diagnosis and monitoring of treatment response in patients with neuroendocrine tumors. Inflammatory cells, including macrophages that are found in sarcoid granulomas, express somatostatin receptors on their surface, whereas normal cardiomyocytes do not. This allows for the potential use of macrophage imaging in cardiac sarcoidosis.
In the CuDOSIS trial, groups A and B (suspected and confirmed cardiac sarcoidosis, respectively) will be scanned with 64Cu-DOTATATE PET/CT in addition to the routinely performed 18F-FDG PET/CT. Further, to examine whether the macrophage infiltration pattern is different in patients with cardiac sarcoidosis and other inflammatory heart diseases, a group of patients with confirmed or clinically suspected myocarditis will be included (group C); this group will only be scanned with 64Cu-DOTATATE PET/CT. Finally, data from a group of patients with neuroendocrine tumours (negative controls) who have previously been scanned with 64Cu-DOTATATE will be included.
- Conditions
- Cardiac Sarcoidosis
- Being tested
- 64Cu-DOTATATE PET/CT scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
64Cu-DOTATATE PET/CT scanDiagnostic test
Patients in group A-C will have a 64Cu-DOTATATE PET/CT scan performed in addition to routine clinical procedures. Group D has had 64Cu-DOTATATE PET/CT performed as part of their clinical diagnostic work-up or follow-up; these data are retrospectively identified and included in the study, and group D will not be subject to any scans in the study.
| Study group | Role | What they receive |
|---|---|---|
| Group A | 22 patients with clinically suspected cardiac sarcoidosis Receives: Diagnostic Test: 64Cu-DOTATATE PET/CT scan | |
| Group B | 22 patients with known cardiac sarcoidosis Receives: Diagnostic Test: 64Cu-DOTATATE PET/CT scan | |
| Group C | Up to 10 patients with clinically suspected or confirmed acute lymphocytic myocarditis Receives: Diagnostic Test: 64Cu-DOTATATE PET/CT scan | |
| Group D | 22 patients with NET without known inflammatory heart disease who have previously been scanned with 64Cu-DOTATATE PET/CT as part of their routine diagnostic work-up or follow-up (control group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tracer uptake - cardiac sarcoidosis and neuroendocrine tumor (negative control)
The proportion of patients with tracer uptake in the heart on 64Cu-DOTATATE PET/CT in patients with verified cardiac sarcoidosis and the proportion of patients without tracer uptake in the heart on 64Cu-DOTATATE PET/CT for patients with a neuroendocrine tumor without a history of inflammatory heart disease (the control group).
Measured: 2 years
Secondary outcomes (3)
24-month rates of adverse outcomes
Death, heart failure hospitalizations, decrease of left ventricular ejection fraction to <10% and <50%, new-onset ventricular tachycardia, new-onset atrioventricular block, implantable cardioverter-defibrillator implantation, shocks from implantable cardioverter-defibrillator, pacemaker implantation, cardiac resyncronization therapy
Measured: 2 years
Tracer uptake - myocarditis
The proportion of patients with tracer uptake in the heart on 64Cu-DOTATATE PET/CT in patients with verified acute lymphocytic myocarditis
Measured: 2 years
Distribution of tracer uptake
The distribution of tracer uptake in the heart in patients with cardiac sarcoidosis and acute lymphocytic myocarditis, respectively
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start1 Nov 2023
- Primary completionJan 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SarcoidosisStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Finn Gustafsson, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Finn Gustafsson, MD,PhD,DMSc, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06131112
- Sponsor's protocol ID
- H-23035676
- Acronym
- CuDOSIS
- Status last verified
- Nov 2023
- First submitted
- 8 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The overall results of the trial will be made available. Individual participant data (IPD) will not be made available.
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Macrophage PET/CT Imaging for the Diagnosis of Cardiac Sarcoidosis
- ClinicalTrials.gov ID
- NCT06131112
- Acronym / sponsor ID
- CuDOSIS / H-23035676
- Conditions
- Cardiac Sarcoidosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 14 Nov 2023 (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.
The purpose of the CuDOSIS study is to examine the diagnostic value of activated macrophage imaging in patients with or under evaluation for cardiac sarcoidosis. The PET/CT tracer 64Cu-DOTATATE is used as a tool to identify activated macrophages. The trial is an open-label prospective study. The study will include 54 participants from the Department of Cardiology and the Department of Clinical Physiology, Nuclear Medicine, and PET at Rigshospitalet. Further, the study will include data from 22 patients with NET who have been scanned with 64Cu-DOTATATE PET/CT previously as negative controls.
Participants will be included in the following groups:
Group A: 22 patients with clinically suspected cardiac sarcoidosis Group B: 22 patients with known cardiac sarcoidosis Group C: Up to 10 patients with clinically suspected or confirmed acute lymphocytic myocarditis Group D: 22 patients with NET without known inflammatory heart disease who have previously been scanned with 64Cu-DOTATATE PET/CT as part of their routine diagnostic work-up or follow-up (control group)
Detailed description
Cardiac involvement is considered a serious condition and a frequent cause of death in patients with sarcoidosis. 18F-FDG PET/CT is currently used as part of the diagnostic criteria for cardiac sarcoidosis, but it has shown limitations in the evaluation of cardiac sarcoidosis due to the high physiological uptake of FDG in normal cardiac muscle. Elaborate preparations are required for patients including either a low-carbohydrate diet followed by long fasting or heparin loading before FDG-PET. In heparin loading, the rare adverse effect of heparin-induced thrombocytopenia should be considered. Therefore, it is of interest to find a PET/CT tracer that displays high sensitivity and specificity without requiring thorough patient preparation and minimizing any adverse effects.
A potential tracer is the somatostatin-based tracer 64Cu-DOTATATE, which is routinely used for the diagnosis and monitoring of treatment response in patients with neuroendocrine tumors. Inflammatory cells, including macrophages that are found in sarcoid granulomas, express somatostatin receptors on their surface, whereas normal cardiomyocytes do not. This allows for the potential use of macrophage imaging in cardiac sarcoidosis.
In the CuDOSIS trial, groups A and B (suspected and confirmed cardiac sarcoidosis, respectively) will be scanned with 64Cu-DOTATATE PET/CT in addition to the routinely performed 18F-FDG PET/CT. Further, to examine whether the macrophage infiltration pattern is different in patients with cardiac sarcoidosis and other inflammatory heart diseases, a group of patients with confirmed or clinically suspected myocarditis will be included (group C); this group will only be scanned with 64Cu-DOTATATE PET/CT. Finally, data from a group of patients with neuroendocrine tumours (negative controls) who have previously been scanned with 64Cu-DOTATATE will be included.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Diagnostic Test: 64Cu-DOTATATE PET/CT scan22 patients with clinically suspected cardiac sarcoidosis |
| Group B | – | Diagnostic Test: 64Cu-DOTATATE PET/CT scan22 patients with known cardiac sarcoidosis |
| Group C | – | Diagnostic Test: 64Cu-DOTATATE PET/CT scanUp to 10 patients with clinically suspected or confirmed acute lymphocytic myocarditis |
| Group D | – | –22 patients with NET without known inflammatory heart disease who have previously been scanned with 64Cu-DOTATATE PET/CT as part of their routine diagnostic work-up or follow-up (control group) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include adults (18 years or older) from the Department of Cardiology and Department of Clinical Physiology, Nuclear Medicine, and PET at Rigshospitalet. The study will include a total of 76 participants: 54 patients from groups A-C and data from 22 patients from group D.
Key inclusion criteria (2 listed)
- Age => 18 years
- Group A: 22 patients with clinically suspected cardiac sarcoidosis Group B: 22 patients with known cardiac sarcoidosis Group C: Up to 10 patients with clinically suspected or confirmed acute lymphocytic myocarditis Group D: 22 patients with NET without known inflammatory heart disease who have previously been scanned with 64Cu-DOTATATE PET/CT as part of their routine diagnostic work-up or follow-up (control group)
Key exclusion criteria (6 listed)
- Severe obesity (weight > 140 kg)
- Pregnancy (negative point-of-care urine/serum human chorion gonadotropin is required in all fertile women)
- Severe claustrophobia
- Known allergy to 64Cu-DOTATATE
- Clinically critical condition which makes PET/CT impossible
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 |
|---|---|---|
| 64Cu-DOTATATE PET/CT scanPatients in group A-C will have a 64Cu-DOTATATE PET/CT scan performed in addition to routine clinical procedures. Group D has had 64Cu-DOTATATE PET/CT performed as part of their clinical diagnostic work-up or follow-up; these data are retrospectively identified and included in the study, and group D will not be subject to any scans in the study. | Diagnostic test | Group A, Group B, Group C |
Primary outcome
Tracer uptake - cardiac sarcoidosis and neuroendocrine tumor (negative control)
Time frame: 2 years
The proportion of patients with tracer uptake in the heart on 64Cu-DOTATATE PET/CT in patients with verified cardiac sarcoidosis and the proportion of patients without tracer uptake in the heart on 64Cu-DOTATATE PET/CT for patients with a neuroendocrine tumor without a history of inflammatory heart disease (the control group).
3 secondary outcomes
24-month rates of adverse outcomes
Time frame: 2 years
Tracer uptake - myocarditis
Time frame: 2 years
Distribution of tracer uptake
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No. The overall results of the trial will be made available. Individual participant data (IPD) will not be made available.
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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.
Finn Gustafsson, MD,PhD,DMSc principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Sarcoidosis, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 2 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 18 Nov 2023. 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 Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Finn Gustafsson, MD,PhD,DMSc (+45 35456340, finn.gustafsson@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tracer uptake - cardiac sarcoidosis and neuroendocrine tumor (negative control) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Nov 2023.