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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2017 by University of Michigan
Sponsor:
Information provided by (Responsible Party):
James R. Corbett, M.D., University of Michigan
ClinicalTrials.gov Identifier:
NCT01433705
First received: September 13, 2011
Last updated: April 14, 2017
Last verified: April 2017

September 13, 2011
April 14, 2017
November 2011
June 2018   (Final data collection date for primary outcome measure)
analysis of healthy cardiac distribution of Rb-82, N-13 ammonia, and F-18 FDG. [ Time Frame: 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.
analysis of healthy cardiac distribution of Rb-82, N-13 ammonia, and F-18 FDG. [ Time Frame: approximately 4 hours ]
Normal healthy volunteers will undergo PET imaging during vasodilator pharmacologic stress with regadenoson and at rest with Rb-82 or N-13 ammonia and at rest with F-18FDG.
Complete list of historical versions of study NCT01433705 on ClinicalTrials.gov Archive Site
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Distribution of Rubidium-82, Nitrogen-13 Ammonia, and Fluorine-18 Fluorodeoxyglucose in Normal Volunteers
Evaluation of the Normal Distribution of Rubidium-82(Rb-82), Nitrogen-13 (N-13)Ammonia, and Fluorine-18 Fluorodeoxyglucose (F-18FDG) in Normal Volunteers

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.

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.

Interventional
Phase 1
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 FDG
Masking: No masking
Primary Purpose: Diagnostic
Heart Disease
  • 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.
  • 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.
  • Rb-82 and N-13 ammonia Pet scans
    Rest and vasodilator stress Rb-82 images or 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 or N-13 ammonia by intravenous administration (IV) in the patient's arm.
    Interventions:
    • Other: Rb-82 Pet scans
    • Other: N-13 ammonia Pet scans
    • Drug: Regadenoson
  • F-18 FDG Imaging and Rb-82
    Volunteers not excluded by abnormal rest/stress imaging with Rb-82, will begin F-18 FDG protocol.
    Interventions:
    • Other: Rb-82 Pet scans
    • Other: F-18 FDG Pet scans
    • Drug: Regadenoson
  • 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.
    Interventions:
    • Other: F-18 FDG Pet scans
    • Other: N-13 ammonia Pet scans
    • Drug: Regadenoson
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
145
June 2018
June 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy normal volunteers

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
Sexes Eligible for Study: All
30 Years to 70 Years   (Adult, Senior)
Yes
Contact: James R. Corbett, M.D. 734-936-5387 jcorbett@med.umich.edu
United States
 
 
NCT01433705
HUM00016183
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
No
Not Provided
James R. Corbett, M.D., University of Michigan
University of Michigan
Not Provided
Principal Investigator: James R. Corbett, M.D. University of Michigan Hospital
University of Michigan
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP