跳至主要内容
临床试验/NCT03923049
NCT03923049终止不适用

Feasibility and Accuracy of Hybrid Magnetic Resonance and Positron Emission Tomography With 18F-Fluorodeoxyglucose in Diagnosing Cardiac Sarcoidosis

University of Alabama at Birmingham2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2019年5月21日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
5
试验地点
2
主要终点
diagnosing cardiac sarcoidosis using combined 18F-FDG-PET/MRI examination

研究概览

简要总结

The purpose and objectives of the study is to establish the feasibility of the simultaneous PET/MR in patients with cardiac sarcoidosis, determine relationships between various imaging biomarkers like extracellular volume (ECV) and standardized uptake values (SUV) from FDG-PET and to evaluate the diagnostic accuracy of the simultaneous method in comparison to the PET/CT and cardiac MRI.

详细描述

Patients who meet the inclusion criteria and agree to the study will be recruited from the Kirklin Clinic and UAB hospitals who will be undergoing FDG-PET/CT for cardiac study as part of their standard of care to diagnose cardiac sarcoidosis. MRI and FDG-PET screening questionnaire will be completed. A chart review will be completed to obtain data from patient medical records pertaining to study including age, gender, race, weight, height, vital signs, social and family history, past medical history especially if there is any history of hypertension, diabetes, high cholesterol levels, heart failure or history of lung diseases, lab results including brain natriuretic peptide levels, creatinine, hemoglobin, coagulation parameters, results of stress test/left heart catheterization, prior echocardiography if available. The CMR will be done solely for research purposes. The patient will be in the PET/MRI scanner for cardiac study only for 60-90 minutes, Finally, multi-sequence, multi-planar cardiac MR images will be acquired to assess cardiac chamber size, regional wall motion abnormalities, ejection fraction, left ventricular perfusion(using gadolinium-based agent) and late gadolinium enhancement.

The investigators will also conduct MRI examinations on 5 healthy volunteers to establish cardiac MRI protocol for the PET/MRI scanner. These scans will not involve any FDG administration to the healthy volunteers. These will involve cardiac MRI examinations to determine the feasibility and quality of MRI scans with the new scanner.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 1.Subjects older than 18 years of age with high suspicion of cardiac sarcoidosis and/or biopsy proven extracardiac sarcoidosis and/or positive HRS criteria will be enrolled.

排除标准

  • Coronary artery disease
  • Insulin dependent diabetes
  • Claustrophobia
  • Pregnancy/nursing
  • Presence of pacemaker or automatic implantable cardioverter-defibrillator
  • Impaired renal function (estimated glomerular filtration rate <45 ml/min/1.73 m2) will be excluded.
  • Inability to undergo PET/MRI due to any other condition.

结局指标

主要结局

diagnosing cardiac sarcoidosis using combined 18F-FDG-PET/MRI examination

时间窗: baseline through 24 hours

diagnostic accuracy of FDG-PET/MRI test will be determined by comparing the PET/MRI test against the Heart Rhythm Society (HRS) criteria which is the standard of reference.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Navkaranbir Bajaj

Principal Investigator

University of Alabama at Birmingham

研究点 (2)

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