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

Sponsor

University of Michigan (Other)

Overall Status

Completed

CT.gov ID

NCT01433705

Collaborator

(none)

Enrollment

Location

Arms

74.6

Actual Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Disease	Other: Rb-82 Pet scans Other: F-18 FDG Pet scans Other: N-13 ammonia Pet scans Drug: Regadenoson	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Subjects will have a PET scan after IV administration of a radio-labelled tracer, Rb-82 and N-13 or injection of F-18 FDGSubjects will have a PET scan after IV administration of a radio-labelled tracer, Rb-82 and N-13 or injection of F-18 FDG

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Evaluation of the Normal Distribution of Rubidium-82(Rb-82), Nitrogen-13 (N-13)Ammonia, and Fluorine-18 Fluorodeoxyglucose (F-18FDG) in Normal Volunteers

Actual Study Start Date :

Nov 1, 2011

Actual Primary Completion Date :

Jan 19, 2018

Actual Study Completion Date :

Jan 19, 2018

Arms and Interventions

Arm	Intervention/Treatment
Other: Rb-82 and 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.	Other: Rb-82 Pet scans Intravenous administration of Rb-82. Images will be taken according to standard clinical imaging protocol and reviewed. Patient will be connected to an EKG machine to monitor the heart. Blood pressure will be monitored as well. For Rb-82 images, 40 mCi (millicuries are a measurement of radioactivity) will be used. Acquisition time for both rest and stress studies should take about 30 min. Other: N-13 ammonia Pet scans Intravenous administration of N-13. Images will be taken according to standard clinical imaging protocol and reviewed. Patient will be connected to an EKG machine to monitor the heart. Blood pressure will be monitored as well. For N-13 ammonia images, 20 mCi (millicuries) will be used. Acquisition time for both rest and stress studies should take about 30 min. Drug: Regadenoson Regadenoson is used as a stressor; but not to study its effects.
Other: F-18 FDG Imaging and Rb-82 Volunteers not excluded by abnormal rest/stress imaging with Rb-82, will begin F-18 FDG protocol.	Other: Rb-82 Pet scans Intravenous administration of Rb-82. Images will be taken according to standard clinical imaging protocol and reviewed. Patient will be connected to an EKG machine to monitor the heart. Blood pressure will be monitored as well. For Rb-82 images, 40 mCi (millicuries are a measurement of radioactivity) will be used. Acquisition time for both rest and stress studies should take about 30 min. Other: F-18 FDG Pet scans Volunteers undergoing the F-18 FDG protocols will undergo: (1) glucose loading protocol for "viability protocol imaging" with the hyperinsulinemic euglycemic clamp according to standard procedures in our laboratory, and (2) "inflammation protocol imaging" using a high fat preparatory diet and three sub-therapeutic heparin doses (10 units / kg each) according to standard laboratory procedure. When metabolically prepared with the viability protocol and the inflammation protocol (two separate days), 10 mCi (millicuries) of F-18 FDG will be administered IV per FDG protocols, via heparin lock. 40-60 minutes after FDG injections PET imaging will be performed according to standard clinical imaging protocol. Drug: Regadenoson Regadenoson is used as a stressor; but not to study its effects.
Other: F-18 FDG Imaging and N-13 ammonia Volunteers not excluded by abnormal rest/stress imaging with N-13 ammonia, will begin F-18 FDG protocol.	Other: F-18 FDG Pet scans Volunteers undergoing the F-18 FDG protocols will undergo: (1) glucose loading protocol for "viability protocol imaging" with the hyperinsulinemic euglycemic clamp according to standard procedures in our laboratory, and (2) "inflammation protocol imaging" using a high fat preparatory diet and three sub-therapeutic heparin doses (10 units / kg each) according to standard laboratory procedure. When metabolically prepared with the viability protocol and the inflammation protocol (two separate days), 10 mCi (millicuries) of F-18 FDG will be administered IV per FDG protocols, via heparin lock. 40-60 minutes after FDG injections PET imaging will be performed according to standard clinical imaging protocol. Other: N-13 ammonia Pet scans Intravenous administration of N-13. Images will be taken according to standard clinical imaging protocol and reviewed. Patient will be connected to an EKG machine to monitor the heart. Blood pressure will be monitored as well. For N-13 ammonia images, 20 mCi (millicuries) will be used. Acquisition time for both rest and stress studies should take about 30 min. Drug: Regadenoson Regadenoson is used as a stressor; but not to study its effects.

Arm

Intervention/Treatment

Other: Rb-82 and 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.

Other: Rb-82 Pet scans

Intravenous administration of Rb-82. Images will be taken according to standard clinical imaging protocol and reviewed. Patient will be connected to an EKG machine to monitor the heart. Blood pressure will be monitored as well. For Rb-82 images, 40 mCi (millicuries are a measurement of radioactivity) will be used. Acquisition time for both rest and stress studies should take about 30 min.

Other: N-13 ammonia Pet scans

Intravenous administration of N-13. Images will be taken according to standard clinical imaging protocol and reviewed. Patient will be connected to an EKG machine to monitor the heart. Blood pressure will be monitored as well. For N-13 ammonia images, 20 mCi (millicuries) will be used. Acquisition time for both rest and stress studies should take about 30 min.

Drug: Regadenoson

Regadenoson is used as a stressor; but not to study its effects.

Other: F-18 FDG Imaging and Rb-82

Volunteers not excluded by abnormal rest/stress imaging with Rb-82, will begin F-18 FDG protocol.

Other: Rb-82 Pet scans

Other: F-18 FDG Pet scans

Volunteers undergoing the F-18 FDG protocols will undergo: (1) glucose loading protocol for "viability protocol imaging" with the hyperinsulinemic euglycemic clamp according to standard procedures in our laboratory, and (2) "inflammation protocol imaging" using a high fat preparatory diet and three sub-therapeutic heparin doses (10 units / kg each) according to standard laboratory procedure. When metabolically prepared with the viability protocol and the inflammation protocol (two separate days), 10 mCi (millicuries) of F-18 FDG will be administered IV per FDG protocols, via heparin lock. 40-60 minutes after FDG injections PET imaging will be performed according to standard clinical imaging protocol.

Drug: Regadenoson

Regadenoson is used as a stressor; but not to study its effects.

Other: F-18 FDG Imaging and N-13 ammonia

Volunteers not excluded by abnormal rest/stress imaging with N-13 ammonia, will begin F-18 FDG protocol.

Other: F-18 FDG Pet scans

Other: N-13 ammonia Pet scans

Drug: Regadenoson

Regadenoson is used as a stressor; but not to study its effects.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy normal volunteers

Exclusion Criteria:

Prior participation in a study with significant radiation exposure
Significant radiation exposure for other reasons, example: routine medical care
Medical history of physical or treadmill exercise stress EKG evidence of heart or vascular disease.
Cardiac A-V conduction abnormalities
Diabetes Mellitus
Liver Disease
Kidney Disease
Other chronic debilitating illnesses ( Example: Rheumatoid Arthritis, Emphysema, Parkinson's Disease).
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
Claustrophobia (fear of tight spaces)
Pregnancy
Inability to lay flat with your arms positioned next to your head for approximately 20 minutes.
Morbid Obesity
Asthma
Breasts Implants
Use of anabolic steroids
Use of recreational drugs

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan Hospital	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

University of Michigan

Investigators

Principal Investigator: James R. Corbett, M.D., University of Michigan Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

James R. Corbett, M.D., Principal Investigator, University of Michigan

ClinicalTrials.gov Identifier:

NCT01433705

Other Study ID Numbers:

HUM00016183

First Posted:

Sep 14, 2011

Last Update Posted:

Jan 30, 2019

Last Verified:

Jan 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by James R. Corbett, M.D., Principal Investigator, University of Michigan

heart

perfusion

glucose

Additional relevant MeSH terms:

Heart Diseases

Regadenoson

Study Results

No Results Posted as of Jan 30, 2019