SarcoidosisEarly Phase 1NCT03048097
Optimizing Acquisition Parameters and Interpretive Methods of FDG-PET/CT With Rb-82
A Early Phase 1 study testing Fluorodeoxyglucose, Rubidium and FDG-PET/CT with Rb82 Myocardial Perfusion Imaging in people with Sarcoidosis, run by Yale University at 1 site in United States.
Trial summary
In this this investigation, 15 subjects with a high probability of cardiac sarcoidosis based on clinical criteria and abnormal cardiac FDG uptake on initial, clinically indicted FDG PET study will be considered for this study. The study will test the following Aims: Aim 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoidosis
- What is being tested?
- Fluorodeoxyglucose, Rubidium and FDG-PET/CT with Rb82 Myocardial Perfusion Imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2017to 2 Jul 2018
- Phase
- Early Phase 1
- 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
- Symptoms
- Palpitations/presyncope/syncope
- Heart failure symptoms Signs
- Abnormal ECG or Holter
- RBBB, LBBB, LAFB
- Abnormal Q waves in ≥2 leads
Show all 11Show fewer
- 1st degree AVB > 240 msec, 2nd/3rd deg. AVB
- Frequent PVCs
- VT (sustained/non-sustained)
- LVEF < 50%
- Cardiac Regional Wall Motion Abnormality
Who cannot join
- Low likelihood of CS/Other explanation for symptoms
- Inability to consent
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Hospital
New Haven, Connecticut, 06510
About this study
Official title: Optimizing Acquisition Parameters and Interpretive Methods of FDG-PET/CT With Rb-82 Myocardial Perfusion Imaging for Evaluation of Cardiac Sarcoidosis
In this this investigation, 15 subjects with a high probability of cardiac sarcoidosis based on clinical criteria and abnormal cardiac FDG uptake on initial, clinically indicted FDG PET study will be considered for this study. The study will test the following Aims:
Aim 1. Effect of FDG incubation time on visual and quantitative interpretation of FDG uptake.
Read more
Changes in incubation time can affect imaging target:background ratios and study sensitivity/specificity. For the study-directed exam, all patients will undergo sequential cardiacfocused FDG-PET imaging at 90 and 120 minutes after injection of FDG. Imaging variables will be evaluated as below.
Aim 2. Reproducibility of FDG and Rb82 PET findings on sequential imaging. It is unknown whether FDG-positive imaging findings in cardiac sarcoidosis are reproducible. All patients will undergo study-directed FDG-PET/CT with MPI imaging within approximately 2 weeks from initial clinical scan.
Read the detailed description
Sarcoidosis is a systemic disease of unknown etiology characterized by non-caseating granulomatous inflammation. The pathophysiologic features of cardiac sarcoidosis include macrophage-induced, T-cell mediated non-caseating granulomatous inflammation, followed by myocardial scarring/fibrosis with clinical sequelae including arrhythmias, conduction abnormalities, and contractile dysfunction. These lead to high event rates in patients with cardiac sarcoidosis, with several studies reporting a prevalence of ventricular tachycardia ranging from 23% to 38% and an ~ 20% rate of clinical congestive heart failure.
FDG-PET/CT with Rb82 myocardial perfusion imaging (FDG-PET with MPI) is becoming the gold standard imaging technique for evaluating the degree of inflammation and the response to immunosuppressive treatment in patients with cardiac sarcoidosis. FDG PET imaging allows for evaluation of inflammatory macrophage infiltration, while Rb82 MPI allows for determination of myocardial scar burden. Despite emerging data from our center and others on the clinical utility of this technique in predicting prognosis, there is little consensus on the reproducibility of this technique or optimal imaging acquisition techniques and interpretative strategies.
In this study, patients with a high clinical likelihood of cardiac sarcoidosis will undergo a study-directed FDG PET/CT with Rb82 myocardial perfusion imaging study approximately 2 weeks following an initial clinically-directed examination.
The two FDG PET with MPI examinations will be examined for reproducibility of imaging findings, including: SUVmax, SUVmean, distribution of FDG uptake, extra cardiac FDG uptake, SUVvolume, SUVvolume:intensity, perfusion defect size/severity/location, LV ejection fraction, myocardial blood flow.
Strict attention will be paid to ensure patients undergo the same metabolic preparation prior to the two examinations.
- Conditions
- Sarcoidosis
- Being tested
- Fluorodeoxyglucose, Rubidium, FDG-PET/CT with Rb82 Myocardial Perfusion Imaging
- Medical subject headings
- Sarcoidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluorodeoxyglucoseDrug
Also called FDG
a radiopharmaceutical used in the medical imaging modality positron emission tomography (PET)
RubidiumDrug
Also called RB82
used in PET scans
FDG-PET/CT with Rb82 Myocardial Perfusion ImagingDiagnostic test
Also called FDG PET
A 18-20 gauge catheter equipped with a 3-way stopcock will be inserted preferably in the antecubital vein. Cardiac FDG-PET imaging will be performed on the YNHH GE Discovery ST PET/CT scanner following a high fat/low carbohydrate diet and a prolonged fast as is current clinical protocol. Resting ECG-gated dynamic Rb-82 PET imaging will be performed using 20-30 mCi of Rb82 as per YNHH clinical imaging protocol and established clinical guidelines. FDG-PET imaging will be performed following a high fat/low carbohydrate diet (instructions provided to patient) and a fast of greater than 12 hours. The patient will be injected with the same dose of FDG (8-10mCi) as they received for their index clinical examination. Cardiac FDG imaging will be performed using a single 3D acquisition over the heart. Low-dose CT images (120 kV, 50-150 mA based on BMI) for the purposes of attenuation correction will be performed before Rb82 and FDG imaging sequences.
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Experimental | Subjects with high-likelihood of cardiac sarcoidosis. Receives: Drug: Fluorodeoxyglucose; Drug: Rubidium; Diagnostic Test: FDG-PET/CT with Rb82 Myocardial Perfusion Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual interpretation of FDG uptake
Images will be evaluated for focal or focal-on-diffuse FDG uptake of the left ventricle or focal RV uptake. The relationship between the location of inflammation and perfusion defects will be characterized ("perfusion metabolism mismatch").
Measured: 90 minutes
Visual interpretation of FDG uptake
Images will be evaluated for focal or focal-on-diffuse FDG uptake of the left ventricle or focal RV uptake. The relationship between the location of inflammation and perfusion defects will be characterized ("perfusion metabolism mismatch").
Measured: 120 minutes
Severity of myocardial inflammation
the maximum standardized uptake value in the heart (cardiac SUV max; g/ml) will be calculated and used to represent the peak level of inflammation.
Measured: 90 minutes
Severity of myocardial inflammation
the maximum standardized uptake value in the heart (cardiac SUV max; g/ml) will be calculated and used to represent the peak level of inflammation.
Measured: 120 minutes
The extent of inflammation
the volume (cm^3) of inflamed myocardium will be calculated using a pre-specified threshold of 2.7 as well as by deriving a unique threshold for each patient by multiplying the background activity x 1.5.
Measured: 90 minutes
The extent of inflammation
the volume (cm^3) of inflamed myocardium will be calculated using a pre-specified threshold of 2.7 as well as by deriving a unique threshold for each patient by multiplying the background activity x 1.5.
Measured: 120 minutes
Secondary outcomes (3)
Visual interpretation of FDG uptake
Images will be evaluated for focal or focal-on-diffuse FDG uptake of the left ventricle or focal RV uptake. The relationship between the location of inflammation and perfusion defects will be characterized ("perfusion
Measured: 2 weeks after initial scan
Severity of myocardial inflammation
the maximum standardized uptake value in the heart (cardiac SUV max; g/ml) will be calculated and used to represent the peak level of inflammation.
Measured: 2 weeks after initial scan
The extent of inflammation
the volume (cm^3) of inflamed myocardium will be calculated using a pre-specified threshold of 2.7 as well as by deriving a unique threshold for each patient by multiplying the background activity x 1.5.
Measured: 2 weeks after initial scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study start1 Feb 2017
- Primary completion2 Jul 2018
- Study completion2 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcoidosisStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A comparison will be made between initial images, and images taken 2 weeks later of the same group of individuals.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edward J Miller, MD PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03048097
- Sponsor's protocol ID
- 1512016912
- Status last verified
- Aug 2019
- First submitted
- 2 Feb 2017
- Last updated
- 26 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alvi RM, Young BD, Shahab Z, Pan H, Winkler J, Herzog E, Miller EJ. Repeatability and Optimization of FDG Positron Emission Tomography for Evaluation of Cardiac Sarcoidosis. JACC Cardiovasc Imaging. 2019 Jul;12(7 Pt 1):1284-1287. doi: 10.1016/j.jcmg.2019.01.011. Epub 2019 Mar 4. No abstract available.
PubMed 30846271
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Acquisition Parameters and Interpretive Methods of FDG-PET/CT With Rb-82 Myocardial Perfusion Imaging for Evaluation of Cardiac Sarcoidosis
- ClinicalTrials.gov ID
- NCT03048097
- Acronym / sponsor ID
- 1512016912
- Conditions
- Sarcoidosis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 2 Jul 2018 (actual)
- Study completion
- 2 Jul 2018 (actual)
- First posted
- 9 Feb 2017 (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.
In this this investigation, 15 subjects with a high probability of cardiac sarcoidosis based on clinical criteria and abnormal cardiac FDG uptake on initial, clinically indicted FDG PET study will be considered for this study. The study will test the following Aims:
Aim 1. Effect of FDG incubation time on visual and quantitative interpretation of FDG uptake.
Changes in incubation time can affect imaging target:background ratios and study sensitivity/specificity. For the study-directed exam, all patients will undergo sequential cardiacfocused FDG-PET imaging at 90 and 120 minutes after injection of FDG. Imaging variables will be evaluated as below.
Aim 2. Reproducibility of FDG and Rb82 PET findings on sequential imaging. It is unknown whether FDG-positive imaging findings in cardiac sarcoidosis are reproducible. All patients will undergo study-directed FDG-PET/CT with MPI imaging within approximately 2 weeks from initial clinical scan.
Detailed description
Sarcoidosis is a systemic disease of unknown etiology characterized by non-caseating granulomatous inflammation. The pathophysiologic features of cardiac sarcoidosis include macrophage-induced, T-cell mediated non-caseating granulomatous inflammation, followed by myocardial scarring/fibrosis with clinical sequelae including arrhythmias, conduction abnormalities, and contractile dysfunction. These lead to high event rates in patients with cardiac sarcoidosis, with several studies reporting a prevalence of ventricular tachycardia ranging from 23% to 38% and an ~ 20% rate of clinical congestive heart failure.
FDG-PET/CT with Rb82 myocardial perfusion imaging (FDG-PET with MPI) is becoming the gold standard imaging technique for evaluating the degree of inflammation and the response to immunosuppressive treatment in patients with cardiac sarcoidosis. FDG PET imaging allows for evaluation of inflammatory macrophage infiltration, while Rb82 MPI allows for determination of myocardial scar burden. Despite emerging data from our center and others on the clinical utility of this technique in predicting prognosis, there is little consensus on the reproducibility of this technique or optimal imaging acquisition techniques and interpretative strategies.
In this study, patients with a high clinical likelihood of cardiac sarcoidosis will undergo a study-directed FDG PET/CT with Rb82 myocardial perfusion imaging study approximately 2 weeks following an initial clinically-directed examination.
The two FDG PET with MPI examinations will be examined for reproducibility of imaging findings, including: SUVmax, SUVmean, distribution of FDG uptake, extra cardiac FDG uptake, SUVvolume, SUVvolume:intensity, perfusion defect size/severity/location, LV ejection fraction, myocardial blood flow.
Strict attention will be paid to ensure patients undergo the same metabolic preparation prior to the two examinations.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A comparison will be made between initial images, and images taken 2 weeks later of the same group of individuals.
| Arm | Type | Receives |
|---|---|---|
| All Participants | Experimental | Drug: Fluorodeoxyglucose, Drug: Rubidium, Diagnostic Test: FDG-PET/CT with Rb82 Myocardial Perfusion ImagingSubjects with high-likelihood of cardiac sarcoidosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Symptoms
- Palpitations/presyncope/syncope
- Heart failure symptoms Signs
- Abnormal ECG or Holter
- RBBB, LBBB, LAFB
Key exclusion criteria (3 listed)
- Low likelihood of CS/Other explanation for symptoms
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 |
|---|---|---|
| FluorodeoxyglucoseAlso: FDGa radiopharmaceutical used in the medical imaging modality positron emission tomography (PET) | Drug | All Participants |
| RubidiumAlso: RB82used in PET scans | Drug | All Participants |
| FDG-PET/CT with Rb82 Myocardial Perfusion ImagingAlso: FDG PETA 18-20 gauge catheter equipped with a 3-way stopcock will be inserted preferably in the antecubital vein. Cardiac FDG-PET imaging will be performed on the YNHH GE Discovery ST PET/CT scanner following a high fat/low carbohydrate diet and a prolonged fast as is current clinical protocol. Resting ECG-gated dynamic Rb-82 PET imaging will be performed using 20-30 mCi of Rb82 as per YNHH clinical imaging protocol and established clinical guidelines. FDG-PET imaging will be performed following a high fat/low carbohydrate diet (instructions provided to patient) and a fast of greater than 12 hours. The patient will be injected with the same dose of FDG (8-10mCi) as they received for their index clinical examination. Cardiac FDG imaging will be performed using a single 3D acquisition over the heart. Low-dose CT images (120 kV, 50-150 mA based on BMI) for the purposes of attenuation correction will be performed before Rb82 and FDG imaging sequences. | Diagnostic test | All Participants |
Primary outcome
Visual interpretation of FDG uptake
Time frame: 90 minutes
Images will be evaluated for focal or focal-on-diffuse FDG uptake of the left ventricle or focal RV uptake. The relationship between the location of inflammation and perfusion defects will be characterized ("perfusion metabolism mismatch").
Visual interpretation of FDG uptake
Time frame: 120 minutes
Images will be evaluated for focal or focal-on-diffuse FDG uptake of the left ventricle or focal RV uptake. The relationship between the location of inflammation and perfusion defects will be characterized ("perfusion metabolism mismatch").
Severity of myocardial inflammation
Time frame: 90 minutes
the maximum standardized uptake value in the heart (cardiac SUV max; g/ml) will be calculated and used to represent the peak level of inflammation.
Severity of myocardial inflammation
Time frame: 120 minutes
the maximum standardized uptake value in the heart (cardiac SUV max; g/ml) will be calculated and used to represent the peak level of inflammation.
The extent of inflammation
Time frame: 90 minutes
the volume (cm^3) of inflamed myocardium will be calculated using a pre-specified threshold of 2.7 as well as by deriving a unique threshold for each patient by multiplying the background activity x 1.5.
The extent of inflammation
Time frame: 120 minutes
the volume (cm^3) of inflamed myocardium will be calculated using a pre-specified threshold of 2.7 as well as by deriving a unique threshold for each patient by multiplying the background activity x 1.5.
3 secondary outcomes
Visual interpretation of FDG uptake
Time frame: 2 weeks after initial scan
Severity of myocardial inflammation
Time frame: 2 weeks after initial scan
The extent of inflammation
Time frame: 2 weeks after initial scan
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 26 Aug 2019.
- Derived from this study: PubMed 30846271Alvi RM, Young BD, Shahab Z, Pan H, Winkler J, Herzog E, Miller EJ. Repeatability and Optimization of FDG Positron Emission Tomography for Evaluation of Cardiac Sarcoidosis. JACC Cardiovasc Imaging. 2019 Jul;12(7 Pt 1):1284-1287. doi: 10.1016/j.jcmg.2019.01.011. Epub 2019 Mar 4. No abstract available.
- 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.
Edward J Miller, MD PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Fluorodeoxyglucose, Rubidium and FDG-PET/CT with Rb82 Myocardial Perfusion Imaging in people with Sarcoidosis, run by Yale University at 1 site in United States.
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 11 inclusion and 3 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 26 Aug 2019. 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 States. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Visual interpretation of FDG uptake (time frame: 90 minutes). The study lists 6 primary outcomes in all. 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 NCT03048097, which also lists 1 linked publication.
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 26 Aug 2019.