Clinical trial NCT03048097: Optimizing Acquisition Parameters and Interpretive Methods of FDG-PET/CT With Rb-82
Official title: Optimizing Acquisition Parameters and Interpretive Methods of FDG-PET/CT With Rb-82 Myocardial Perfusion Imaging for Evaluation of Cardiac Sarcoidosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Sarcoidosis
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2017-02-09
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A comparison will be made between initial images, and images taken 2 weeks later of the same group of individuals.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual interpretation of FDG uptake
timeFrame: 90 minutes
measure: Visual interpretation of FDG uptake
timeFrame: 120 minutes
measure: Severity of myocardial inflammation
timeFrame: 90 minutes
measure: Severity of myocardial inflammation
timeFrame: 120 minutes
measure: The extent of inflammation
timeFrame: 90 minutes
measure: The extent of inflammation
timeFrame: 120 minutes
Secondary outcomes:
measure: Visual interpretation of FDG uptake
timeFrame: 2 weeks after initial scan
measure: Severity of myocardial inflammation
timeFrame: 2 weeks after initial scan
measure: The extent of inflammation
timeFrame: 2 weeks after initial scan
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Edward J Miller, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.