NCT02043522

123I-mIBG SPECT Imaging

Optimization of Cardiac Iodine-123 Meta-iodobenzylguanidine (123I-mIBG) SPECT Imaging

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Ottawa Heart Institute Research Corporation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study is being done with a radioisotope, 123I-mIBG (Adreview), to develop a nuclear diagnostic imaging test for patients with decreased heart function which can be used to predict the progression of the heart disease and provide the appropriate clinical treatment. The types of patients to be studied include patients who have had a heart attack where heart muscle may be damaged and patients diagnosed with heart failure who have enlarged hearts. Both conditions may cause poor muscle contraction and disturbances in electrical signal conduction. There will also be a control group of participants with no evidence of heart disease. 123I-mIBG has been shown to be effective in assessing the areas of the heart being activated involuntarily by the sympathetic nervous system (SNS). 123I-mIBG is an iodine based radioisotope that is chemically similar to norepinephrine (NE) in the heart. NE is responsible for the way the SNS regulates heart functions such as heart rate and the force of heart contractions. NE acts automatically to maintain a homeostasis or balance within the SNS. The amount of 123I-mIBG, mimicking NE, that appears on the nuclear image using the heart-to-mediastinum ratio (H/M ratio), was predictive of the progression of heart failure, arrhythmias (irregular heartbeats) and cardiac death. Two different types of single photon emission computed tomography (SPECT) imaging will be used: standard SPECT and cadmium-zinc-telluride (CZT) SPECT. The investigators hypothesize that CZT SPECT will have greater H/M ratios than standard SPECT imaging.

Detailed description

123I-mIBG (MIBG) cardiac scintigraphy can be used to assess cardiac sympathetic activity and predicts prognosis in patients with heart failure. The results of prognostic studies were validated in the AdreView Myocardial Imaging for Risk Evaluation in Heart Failure (ADMIRE-HF) trial, which was a large multi-centre prospective international study of 961 patients with NYHA Class II - III Heart Failure and LV ejection fraction \> 35%2. This landmark study used planar imaging for calculation of the heart-to-mediastinal ratio (H/M) as a quantitative analysis of global uptake. The H/M on 4 hour delayed planar imaging was predictive of heart failure progression, arrhythmic events and cardiac death and provided incremental value to B-type natriuretic peptide and left ventricular (LV) ejection fraction. In a study using quantitative MIBG SPECT, a new method for the calculation of the H/M ratio was developed, compared several reconstruction methods and demonstrated that the H/M ratio from SPECT was equivalent to the planar H/M ratio for differentiating normal participants from heart failure patients. The ability of SPECT imaging to provide more accurate quantitative measurement of myocardial activity may also provide more accurate measurements of MIBG washout, which has been shown to be predictive of sudden cardiac death using planar imaging. SPECT imaging also can provide information about the regional distribution of MIBG, which has been demonstrated to be predictive of sudden cardiac death. Similarly, mismatch of regional MIBG uptake and perfusion reflecting deinnervation of viable tissue may identify myocardium with potential for development of ventricular arrhythmias. Thus, SPECT MIBG imaging may provide much useful prognostic information in addition to the H/M ratio. Participants will have a single dose of the isotope and the H/M ratio will be measured using 3 types of imaging techniques with cameras and software currently used at the University of Ottawa Heart Institute: 1. Planar (2D) imaging, as used in the ADMIRE-HF trial 2. Hawkeye Infinia 3D SPECT imaging, which is conventional SPECT 3. Discovery NM-530 CZT 3D SPECT imaging, a newer SPECT technology Images will be taken at predetermined time points over a 5 hour period on the study /injection day. Participants will be monitored for any clinical changes with routine lab work and physical observations during the study.

Conditions

• Heart Failure
• Coronary Artery Disease

Interventions

Type	Name	Description
DRUG	Radioisotope	One dose of 10 mCi (370 mBq:± 10%, calibrated to time of injection) of 123I-mIBG (AdreView) administered as a single intravenous bolus over 1 or 2 minutes, followed by a saline flush.

Timeline

• Start date: 2013-12-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2014-01-23
• Last updated: 2017-04-24

Locations

1 site across 1 country: Canada