Cardiac SarcoidosisNCT03705884
PET/MR Imaging In Patients With Cardiac Sarcoidosis
A study testing 18F-FDG and Prednisolone in people with Cardiac Sarcoidosis, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
PET scanning (positron emission tomography) is a well-established technique used to identify areas of interest within the body. It involves injecting a radioactive tracer which highlights abnormal areas. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac Sarcoidosis
- What is being tested?
- 18F-FDG and Prednisolone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Oct 2017to 1 Dec 2018
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Cardiac Sarcoidosis Patients:
- Aged over 40 years
- Completion of informed consent
- Established diagnosis of cardiac sarcoidosis
- Established diagnosis as per HRS recommended diagnostic criteria
- Healthy Volunteers:
- Aged over 40
- Completion of informed consent
Who cannot join
- All participants:
- Inability or unwilling to give informed consent
- Women who are pregnant, breastfeeding or of child-bearing potential (women who have experienced menarche, are pre-menopausal and have not been sterilised) will not be enrolled into the trial.
- Major intercurrent illness with life-expectancy <2 years.
- Renal dysfunction (eGFR less than or equal to 30ml/min/1.73m2)
- Adverse reaction or hypersensitivity to 18F-FDG PET tracer
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- NYHA Class IV heart failure
- Patients with atrial fibrillation and poor rate control
- Contraindications to MRI scanning
- Previous history of contrast allergy of adverse reactions (Gadolinium-containing agents)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queen's Medical Research Institute
Edinburgh, Midlothian, EH16 4TJ
About this study
Official title: Molecular Imaging in Cardiovascular Disease Using Hybrid Positron Emission Tomography/Magnetic Resonance Imaging (PET/MR): Cardiac Sarcoidosis
PET scanning (positron emission tomography) is a well-established technique used to identify areas of interest within the body. It involves injecting a radioactive tracer which highlights abnormal areas. It has recently been combined with CT (computed tomography) and MRI (magnetic resonance imaging) scanning to more accurately identify abnormalities within the heart. Cardiac sarcoidosis, a condition which causes scarring and inflammation within the heart muscle, is of particular interest.
The study makes use of hybrid PET/MR scanning using a designated scanner which enables PET scanning combined with MRI scanning. This will allow imaging of abnormal areas within the heart in this condition alongside treatment regimens in a way which hasn't been done before. If successful, this imaging method will play a key role in diagnosing, quantifying and monitoring these conditions.
All participants will undergo PET scanning, where a radioactive tracer is injected into a vein before the scan. The radioactive substance only lasts for a short time and is safe, passed out of the body in urine. The scan will be performed twice; once before treatment and once after treatment has been established. A cohort of healthy volunteers will undergo scanning in exactly the same way to enable us to compare the results with hearts of people who don't have cardiac sarcoidosis.
- Conditions
- Cardiac Sarcoidosis
- Being tested
- 18F-FDG, Prednisolone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FDGOther
Hybrid 18F-FDG PET/MR imaging for observational diagnostic purposes.
PrednisoloneDrug
Oral course of Prednisolone for treatment of sarcoidosis (patient cohort) or as control (healthy volunteer cohort)
| Study group | Role | What they receive |
|---|---|---|
| Cardiac Sarcoidosis | Other | Patients with an established diagnosis of cardiac sarcoidosis. Receives: Other: 18F-FDG; Drug: Prednisolone |
| Healthy volunteers | Other | Healthy volunteer subjects of similar age and gender to patient cohort. Receives: Other: 18F-FDG; Drug: Prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial 18F-FDG uptake
Quantification of myocardial PET tracer uptake before steroid therapy
Measured: Within 1 year
Myocardial 18F-FDG uptake
Quantification of myocardial PET tracer uptake after steroid therapy
Measured: Within 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start30 Oct 2017
- Primary completion1 Dec 2018
- Study completion1 Dec 2018
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 University of EdinburghThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients and healthy subjects will be allocated in a non-randomised fashion to either corticosteroid or control arms, for parallel comparison within the two groups. The corticosteroid is recognised treatment for the condition and is being used to observe the impact on diagnostic imaging; no treatment effects are being studied or are endpoints of the study (i.e. the study is not a clinical trial of treatment in cardiac sarcoidosis with corticosteroid).
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc R Dweck, MD PhD, Study director, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03705884
- Sponsor's protocol ID
- AC17010
- Status last verified
- May 2024
- First submitted
- 8 Aug 2018
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Imaging in Cardiovascular Disease Using Hybrid Positron Emission Tomography/Magnetic Resonance Imaging (PET/MR): Cardiac Sarcoidosis
- ClinicalTrials.gov ID
- NCT03705884
- Acronym / sponsor ID
- AC17010
- Conditions
- Cardiac Sarcoidosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- 30 Oct 2017 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 15 Oct 2018 (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.
PET scanning (positron emission tomography) is a well-established technique used to identify areas of interest within the body. It involves injecting a radioactive tracer which highlights abnormal areas. It has recently been combined with CT (computed tomography) and MRI (magnetic resonance imaging) scanning to more accurately identify abnormalities within the heart. Cardiac sarcoidosis, a condition which causes scarring and inflammation within the heart muscle, is of particular interest.
The study makes use of hybrid PET/MR scanning using a designated scanner which enables PET scanning combined with MRI scanning. This will allow imaging of abnormal areas within the heart in this condition alongside treatment regimens in a way which hasn't been done before. If successful, this imaging method will play a key role in diagnosing, quantifying and monitoring these conditions.
All participants will undergo PET scanning, where a radioactive tracer is injected into a vein before the scan. The radioactive substance only lasts for a short time and is safe, passed out of the body in urine. The scan will be performed twice; once before treatment and once after treatment has been established. A cohort of healthy volunteers will undergo scanning in exactly the same way to enable us to compare the results with hearts of people who don't have cardiac sarcoidosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients and healthy subjects will be allocated in a non-randomised fashion to either corticosteroid or control arms, for parallel comparison within the two groups. The corticosteroid is recognised treatment for the condition and is being used to observe the impact on diagnostic imaging; no treatment effects are being studied or are endpoints of the study (i.e. the study is not a clinical trial of treatment in cardiac sarcoidosis with corticosteroid).
| Arm | Type | Receives |
|---|---|---|
| Cardiac Sarcoidosis | Other | Other: 18F-FDG, Drug: PrednisolonePatients with an established diagnosis of cardiac sarcoidosis. |
| Healthy volunteers | Other | Other: 18F-FDG, Drug: PrednisoloneHealthy volunteer subjects of similar age and gender to patient cohort. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged over 40 years
- Completion of informed consent
- Established diagnosis of cardiac sarcoidosis
- Established diagnosis as per HRS recommended diagnostic criteria
- Aged over 40
Key exclusion criteria (10 listed)
- All participants:
- Inability or unwilling to give informed consent
- Women who are pregnant, breastfeeding or of child-bearing potential (women who have experienced menarche, are pre-menopausal and have not been sterilised) will not be enrolled into the trial.
- Major intercurrent illness with life-expectancy <2 years.
- Renal dysfunction (eGFR less than or equal to 30ml/min/1.73m2)
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 |
|---|---|---|
| 18F-FDGHybrid 18F-FDG PET/MR imaging for observational diagnostic purposes. | Other | Cardiac Sarcoidosis, Healthy volunteers |
| PrednisoloneOral course of Prednisolone for treatment of sarcoidosis (patient cohort) or as control (healthy volunteer cohort) | Drug | Cardiac Sarcoidosis, Healthy volunteers |
Primary outcome
Myocardial 18F-FDG uptake
Time frame: Within 1 year
Quantification of myocardial PET tracer uptake before steroid therapy
Myocardial 18F-FDG uptake
Time frame: Within 1 year
Quantification of myocardial PET tracer uptake after steroid therapy
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 17 May 2024.
- Individual participant dataSharing planned: No
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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.
Marc R Dweck, MD PhD study director
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18F-FDG and Prednisolone in people with Cardiac Sarcoidosis, run by University of Edinburgh at 1 site in United Kingdom.
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 8 inclusion and 10 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 17 May 2024. 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 United Kingdom. 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?
Myocardial 18F-FDG uptake (time frame: Within 1 year). 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 17 May 2024.