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

NCT01433705 | Completed Phase 1 FDA Drug

• 1 other identifier: HUM00016183
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Disease

Keywords

heart; perfusion; glucose

Outcome Measures

Primary Outcomes (1)

• analysis of healthy cardiac distribution of Rb-82, N-13 ammonia, and F-18 FDG.

  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.

  approximately 4 to 10 hours

Study Arms (3)

Rb-82 and N-13 ammonia Pet scans

OTHER

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; Other: N-13 ammonia Pet scans; Drug: Regadenoson

F-18 FDG Imaging and Rb-82

OTHER

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; Drug: Regadenoson

F-18 FDG Imaging and N-13 ammonia

OTHER

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

Interventions

Rb-82 Pet scans OTHER

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.

F-18 FDG Imaging and Rb-82; Rb-82 and N-13 ammonia Pet scans

F-18 FDG Pet scans OTHER

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.

F-18 FDG Imaging and N-13 ammonia; F-18 FDG Imaging and Rb-82

N-13 ammonia Pet scans OTHER

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.

F-18 FDG Imaging and N-13 ammonia; Rb-82 and N-13 ammonia Pet scans

Regadenoson DRUG

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

F-18 FDG Imaging and N-13 ammonia; F-18 FDG Imaging and Rb-82; Rb-82 and N-13 ammonia Pet scans

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy normal volunteers

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Heart Diseases

Interventions

regadenoson

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• James R. Corbett, M.D.

  University of Michigan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: September 13, 2011
• First Posted: September 14, 2011
• Study Start: November 1, 2011
• Primary Completion: January 19, 2018
• Study Completion: January 19, 2018
• Last Updated: January 30, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)