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

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ClinicalTrials.gov Identifier: NCT03048097
Recruitment Status : Completed
First Posted : February 9, 2017
Last Update Posted : July 4, 2018
Sponsor:
Information provided by (Responsible Party):
Yale University

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.


Condition or disease Intervention/treatment Phase
Sarcoidosis Drug: Fluorodeoxyglucose Drug: Rubidium Diagnostic Test: FDG-PET/CT with Rb82 Myocardial Perfusion Imaging Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Intervention 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)
Masking Description: images will be interpreted without identification
Primary Purpose: Diagnostic
Official Title: Optimizing Acquisition Parameters and Interpretive Methods of FDG-PET/CT With Rb-82 Myocardial Perfusion Imaging for Evaluation of Cardiac Sarcoidosis
Actual Study Start Date : February 1, 2017
Actual Primary Completion Date : July 2, 2018
Actual Study Completion Date : July 2, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sarcoidosis

Arm Intervention/treatment
Experimental: All Participants
Subjects with high-likelihood of cardiac sarcoidosis.
Drug: Fluorodeoxyglucose
a radiopharmaceutical used in the medical imaging modality positron emission tomography (PET)
Other Name: FDG

Drug: Rubidium
used in PET scans
Other Name: RB82

Diagnostic Test: FDG-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.
Other Name: FDG PET




Primary Outcome Measures :
  1. 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").

  2. 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").

  3. 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.

  4. 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.

  5. 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.

  6. 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.


Secondary Outcome Measures :
  1. Visual interpretation of FDG uptake [ Time Frame: 2 weeks after initial scan ]
    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

  2. Severity of myocardial inflammation [ Time Frame: 2 weeks after initial scan ]
    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.

  3. The extent of inflammation [ Time Frame: 2 weeks after initial scan ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03048097


Locations
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United States, Connecticut
Yale New Haven Hospital
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Edward J Miller, MD PhD Yale University

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03048097     History of Changes
Other Study ID Numbers: 1512016912
First Posted: February 9, 2017    Key Record Dates
Last Update Posted: July 4, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Sarcoidosis
Lymphoproliferative Disorders
Lymphatic Diseases
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action