NCT03048097

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 2, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 9, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2018

Completed
Last Updated

August 26, 2019

Status Verified

August 1, 2019

Enrollment Period

1.4 years

First QC Date

February 2, 2017

Last Update Submit

August 21, 2019

Conditions

Sarcoidosis

Outcome Measures

Primary Outcomes (6)

  • 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").

    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").

    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.

    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.

    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.

    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.

    120 minutes

Secondary Outcomes (3)

  • Visual interpretation of FDG uptake

    2 weeks after initial scan

  • Severity of myocardial inflammation

    2 weeks after initial scan

  • The extent of inflammation

    2 weeks after initial scan

Study Arms (1)

All Participants

EXPERIMENTAL

Subjects with high-likelihood of cardiac sarcoidosis.

Drug: FluorodeoxyglucoseDrug: RubidiumDiagnostic Test: FDG-PET/CT with Rb82 Myocardial Perfusion Imaging

Interventions

FluorodeoxyglucoseDRUG

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

Also known as: FDG
All Participants
RubidiumDRUG

used in PET scans

Also known as: RB82
All Participants
FDG-PET/CT with Rb82 Myocardial Perfusion ImagingDIAGNOSTIC_TEST

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.

Also known as: FDG PET
All Participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Related Publications (1)

  • 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.

    PMID: 30846271DERIVED

MeSH Terms

Conditions

Sarcoidosis

Interventions

Fluorodeoxyglucose F18Rubidium

Condition Hierarchy (Ancestors)

Lymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

DeoxyglucoseDeoxy SugarsCarbohydratesMetals, AlkaliElementsInorganic ChemicalsMetals, HeavyMetals

Study Officials

  • Edward J Miller, MD PhD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Masking Details
images will be interpreted without identification
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: A comparison will be made between initial images, and images taken 2 weeks later of the same group of individuals.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2017

First Posted

February 9, 2017

Study Start

February 1, 2017

Primary Completion

July 2, 2018

Study Completion

July 2, 2018

Last Updated

August 26, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)