Cardiac SarcoidosisNCT02812849
Somatostatin Receptor Imaging in 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 trial is to determine the accuracy of Cu-64 labelled DOTATATE for diagnosing cardiac sarcoidosis using PET/CT or PET/MRI. 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?
- Cu-64 DOTATATE
- How many people
- 0 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2016to 27 Feb 2020
- Phase
- Observational
- 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
Study population: Patients with suspected or known cardiac sarcoidosis or with myocarditis/dilated cardiomyopathy
Who may be able to join
- Group A: Suspected cardiac sarcoidosis Group B: Known cardiac sarcoidosis, clinical follow-up Group C: Myocarditis or dilated cardiomyopathy (Non-cardiac sarcoidosis)
Who cannot join
- Infection Pregnancy Severe claustrophobia Weight >140 kg
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the trial is to determine the accuracy of Cu-64 labelled DOTATATE for diagnosing cardiac sarcoidosis using PET/CT or PET/MRI.
- Conditions
- Cardiac Sarcoidosis
- Being tested
- Cu-64 DOTATATE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cu-64 DOTATATEDrug
| Study group | Role | What they receive |
|---|---|---|
| Suspected cardiac sarcoidosis | Cu-64 DOTATATE PET/CT or PET/MRI Receives: Drug: Cu-64 DOTATATE | |
| Known cardiac sarcoidosis | Cu-64 DOTATATE PET/CT or PET/MRI Receives: Drug: Cu-64 DOTATATE | |
| Other inflammatory cardiac disease | Cu-64 DOTATATE PET/CT or PET/MRI Receives: Drug: Cu-64 DOTATATE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity to detect cardiac sarcoidosis
Measured: 1 day at PET/CT examination
Specificity to detect cardiac sarcoidosis
Measured: 1 day at PET/CT examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionNov 2019 (estimated)
- Study completion27 Feb 2020
Why it stopped: Logistic reasons
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rasmus S. Ripa, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Rasmus S Ripa, MD, DMSc, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02812849
- Sponsor's protocol ID
- 0001
- Status last verified
- Oct 2020
- First submitted
- 22 Jun 2016
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Somatostatin Receptor Imaging in Cardiac Sarcoidosis
- ClinicalTrials.gov ID
- NCT02812849
- Acronym / sponsor ID
- 0001
- Conditions
- Cardiac Sarcoidosis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Logistic reasons
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Nov 2019 (estimated)
- Study completion
- 27 Feb 2020 (actual)
- First posted
- 24 Jun 2016 (estimated)
- 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 trial is to determine the accuracy of Cu-64 labelled DOTATATE for diagnosing cardiac sarcoidosis using PET/CT or PET/MRI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Suspected cardiac sarcoidosis | – | Drug: Cu-64 DOTATATECu-64 DOTATATE PET/CT or PET/MRI |
| Known cardiac sarcoidosis | – | Drug: Cu-64 DOTATATECu-64 DOTATATE PET/CT or PET/MRI |
| Other inflammatory cardiac disease | – | Drug: Cu-64 DOTATATECu-64 DOTATATE PET/CT or PET/MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with suspected or known cardiac sarcoidosis or with myocarditis/dilated cardiomyopathy
Key inclusion criteria (1 listed)
- Group A: Suspected cardiac sarcoidosis Group B: Known cardiac sarcoidosis, clinical follow-up Group C: Myocarditis or dilated cardiomyopathy (Non-cardiac sarcoidosis)
Key exclusion criteria (1 listed)
- Infection Pregnancy Severe claustrophobia Weight >140 kg
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 |
|---|---|---|
| Cu-64 DOTATATE | Drug | Known cardiac sarcoidosis, Other inflammatory cardiac disease, Suspected cardiac sarcoidosis |
Primary outcome
Sensitivity to detect cardiac sarcoidosis
Time frame: 1 day at PET/CT examination
Specificity to detect cardiac sarcoidosis
Time frame: 1 day at PET/CT examination
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Individual participant dataSharing planned: Undecided
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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.
Rasmus S Ripa, MD, 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 14 Oct 2020. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Sensitivity to detect cardiac sarcoidosis (time frame: 1 day at PET/CT examination). The study lists 2 primary outcomes in all. 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 14 Oct 2020.