Distribution of Rubidium-82, Nitrogen-13 Ammonia, and Fluorine-18 Fluorodeoxyglucose in Normal Volunteers

Phase 1

Completed

• Conditions: Heart Disease
• Interventions: Other: Rb-82 Pet scans; Other: N-13 ammonia Pet scans; Other: F-18 FDG Pet scans; Drug: Regadenoson

• Registration Number: NCT01433705
• Lead Sponsor: University of Michigan

Brief Summary

Establish the normal distributions of Rb-82, N-13 ammonia, and F-18 FDG (radioactive tracers) in the heart using PET imaging. These tracers would be eventually used in evaluating the hearts of patients with heart disease.

Normal healthy volunteers will be carefully screened for this study. Subjects will be given IV administration of Rb-82 and N-13 to acquire rest/stress imaging. Normal subjects not excluded by any unexpected abnormality during the Rb-82 or N-13 rest/stress studies will undergo a glucose loading F-18 FDG imaging protocol, viability protocol using the hyperinsulinemic euglycemic clamp with simultaneous IV infusions of dextrose and insulin according to standard procedures in our laboratory.

These same subjects will have a F-18 FDG protocol after following a high fat, protein permitted, no carbohydrate diet for approximately 30 hours prior to F-18 FDG injection. The F-18 FDG radiotracer will be given through an IV.

Detailed Description

Cardiac rubidium-82(Rb-82)and N-13 ammonia heart perfusion (blood flow) studies and florine-18 fluorodeoxyglucose (F-18FDG) heart PET glucose metabolism studies are important tools for evaluating patients with coronary heart disease.

This includes patients with known or suspected heart disease and patients with congestive heart failure following myocardial infarction (heart attack) with indeterminant assessments of cardiac health from other types of imaging, such as SPECT perfusion imaging and echocardiography.

These studies help physicians plan potentially life saving procedures to re-establish coronary blood flow to living but severely compromised heart muscle. Rb-82 and N-13 ammonia studies can tell if there is reduced blood flow to the heart muscle either at rest or during stress.

FDG studies can tell whether there is any chance of a beneficial effect from coronary revascularization procedures, for example coronary angioplasties and stents or coronary artery bypass. Revascularization procedures in patients like these may be technically difficult, risky and costly.

Unfortunately the normal cardiac distributions of Rb-82, N-13 and ammonia, and F-18FDG for computer analysis of human studies are not well known and what is known is not widely available for clinical use. The latest imaging guidelines from the American Society of Nuclear Cardiology recommend that Rb-82, N-13 ammonia, and FDG cardiac studies be compared to normal distributions or patterns of these radiotracers in the heart developed from a series of normal individuals.

The purpose for these studies is to generate databases of normal Rb-82, N-13 ammonia, and F-18FDG cardiac distributions so that they can be used in the analysis of clinical patient studies at the University of Michigan Hospital.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2011-09-13
• Study First Submitted QC: 2011-09-13
• Study First Posted: 2011-09-14
• Study Start: 2011-11
• Primary Completion: 2018-01-19
• Study Completion: 2018-01-19
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-28
• Last Update Posted: 2019-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Healthy normal volunteers

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Exclusion Criteria

1. Prior participation in a study with significant radiation exposure
2. Significant radiation exposure for other reasons, example: routine medical care
3. Medical history of physical or treadmill exercise stress EKG evidence of heart or vascular disease.
4. Cardiac A-V conduction abnormalities
5. Diabetes Mellitus
6. Liver Disease
7. Kidney Disease
8. Other chronic debilitating illnesses ( Example: Rheumatoid Arthritis, Emphysema, Parkinson's Disease).
9. Tobacco use, hypertension, diabetes, family history of coronary artery disease before age 45 in males and 55 in females or other coronary risks factors of more than mild severity
10. Claustrophobia (fear of tight spaces)
11. Pregnancy
12. Inability to lay flat with your arms positioned next to your head for approximately 20 minutes.
13. Morbid Obesity
14. Asthma
15. Breasts Implants
16. Use of anabolic steroids
17. Use of recreational drugs

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rb-82 and N-13 ammonia Pet scans	Regadenoson	Rest and vasodilator stress Rb-82 images and N-13 ammonia images will be taken according to standard clinical imaging protocol. Each of these two imaging studies require the injection of Rb-82 and N-13 ammonia by intravenous administration (IV) in the patient's arm.
F-18 FDG Imaging and N-13 ammonia	N-13 ammonia Pet scans	Volunteers not excluded by abnormal rest/stress imaging with N-13 ammonia, will begin F-18 FDG protocol.
Rb-82 and N-13 ammonia Pet scans	N-13 ammonia Pet scans	Rest and vasodilator stress Rb-82 images and N-13 ammonia images will be taken according to standard clinical imaging protocol. Each of these two imaging studies require the injection of Rb-82 and N-13 ammonia by intravenous administration (IV) in the patient's arm.
Rb-82 and N-13 ammonia Pet scans	Rb-82 Pet scans	Rest and vasodilator stress Rb-82 images and N-13 ammonia images will be taken according to standard clinical imaging protocol. Each of these two imaging studies require the injection of Rb-82 and N-13 ammonia by intravenous administration (IV) in the patient's arm.
F-18 FDG Imaging and Rb-82	Rb-82 Pet scans	Volunteers not excluded by abnormal rest/stress imaging with Rb-82, will begin F-18 FDG protocol.
F-18 FDG Imaging and Rb-82	Regadenoson	Volunteers not excluded by abnormal rest/stress imaging with Rb-82, will begin F-18 FDG protocol.
F-18 FDG Imaging and Rb-82	F-18 FDG Pet scans	Volunteers not excluded by abnormal rest/stress imaging with Rb-82, will begin F-18 FDG protocol.
F-18 FDG Imaging and N-13 ammonia	F-18 FDG Pet scans	Volunteers not excluded by abnormal rest/stress imaging with N-13 ammonia, will begin F-18 FDG protocol.
F-18 FDG Imaging and N-13 ammonia	Regadenoson	Volunteers not excluded by abnormal rest/stress imaging with N-13 ammonia, will begin F-18 FDG protocol.

Primary Outcome Measures

Name	Time	Method
analysis of healthy cardiac distribution of Rb-82, N-13 ammonia, and F-18 FDG.	approximately 4 to 10 hours	Normal healthy volunteers will undergo PET imaging during vasodilator pharmacologic stress with regadenoson and at rest with Rb-82 and or N-13 ammonia and or at rest with F-18FDG. Participants will have either rest and stress Rb-82 and rest and stress N-13 ammonia or one of these stress tests and F-18 FDG imaging.

Trial Locations

Locations (1)

University of Michigan Hospital; 🇺🇸 Ann Arbor, Michigan, United States