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Optimizing Acquisition Parameters and Interpretive Methods of FDG-PET/CT With Rb-82

Optimizing Acquisition Parameters and Interpretive Methods of FDG-PET/CT With Rb-82 Myocardial Perfusion Imaging for Evaluation of Cardiac Sarcoidosis

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03048097
Enrollment
15
Registered
2017-02-09
Start date
2017-02-01
Completion date
2018-07-02
Last updated
2019-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcoidosis

Brief 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. 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.

Interventions

a radiopharmaceutical used in the medical imaging modality positron emission tomography (PET)

DRUGRubidium

used in PET scans

DIAGNOSTIC_TESTFDG-PET/CT with Rb82 Myocardial Perfusion Imaging

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.

Sponsors

Yale University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Masking description

images will be interpreted without identification

Intervention model description

A comparison will be made between initial images, and images taken 2 weeks later of the same group of individuals.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Symptoms * Palpitations/presyncope/syncope * Heart failure symptoms Signs * Abnormal ECG or Holter * RBBB, LBBB, LAFB * Abnormal Q waves in ≥2 leads * 1st degree AVB \> 240 msec, 2nd/3rd deg. AVB * Frequent PVCs * VT (sustained/non-sustained) * LVEF \< 50% * Cardiac Regional Wall Motion Abnormality

Exclusion criteria

* Low likelihood of CS/Other explanation for symptoms * Inability to consent * Pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Visual interpretation of FDG uptake90 minutesImages 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 inflammation90 minutesthe 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 inflammation90 minutesthe 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.

Secondary

MeasureTime frameDescription
Visual interpretation of FDG uptake2 weeks after initial scanImages 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
Severity of myocardial inflammation2 weeks after initial scanthe 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 inflammation2 weeks after initial scanthe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026