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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 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: June 12, 2014
Last verified: June 2014
  Purpose

Establish the normal distributions of Rb-82, N-13 ammonia, and F-18 FDG in the heart using PET imaging for subsequent use in the evaluation of U of M clinical patient studies using these procedures. Normal healthy volunteers will be extensively 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 individuals will also undergo an inflammation 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 administered IV per protocol.


Condition Intervention Phase
Heart Disease
Procedure: Rb-82 and N-13 ammonia imaging
Procedure: F-18 FDG imaging
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Evaluation of the Normal Distribution of RubiniumRubidium-82(Rb-82), Nitrogen-13 (N-13)Ammonia, and Florine-18 Fluorodeoxyglucose (F-18FDG)in Normal Volunteers

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • analysis of healthy cardiac distribution of Rb-82, N-13 ammonia, and F-18 FDG. [ Time Frame: approximately 4 to 10 hours ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 145
Study Start Date: August 2011
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Rb-82 or N-13 images acquired
Rest and vasodilator stress Rb-82 images or N-13 ammonia images will be acquired according to standard clinical imaging protocol and reviewed. Each of these two studies require the injection of Rb-82 by intravenous administration (IV)which will be started in the patient's arm.
Procedure: Rb-82 and N-13 ammonia imaging
Intravenous administration of Rb-82 and N-13. Images will be acquired according to standard clinical imaging protocol and reviewed. Patient will be connected to an EKG machine to monitor the heart and blood pressure will be monitored as well. For Rb-82 images, 40 mCi(millicuries/a measurement of radioactivity) will be used. For N-13 ammonia images, 20 mCi (millicuries)will be used. Acquisition time for both rest and stress studies to be completed should take approximately 30 min.
F-18 FDG Imaging
Volunteers not excluded by abnormal rest/stress Rb-82 or N-13 ammonia imaging will begin F-18 FDG protocol.
Procedure: F-18 FDG imaging
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 procedure in our laboratory. 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 following FDG injections PET imaging will be performed according to standard clinical imaging protocol.

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 the evaluation of 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 imaging modalities, for example SPECT perfusion imaging and echocardiography. These studies help physicians plan potentially life saving procedures to re-establish coronary blood flow to living but severly 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.

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01433705

Contacts
Contact: James R. Corbett, M.D. 734-936-5387 jcorbett@med.umich.edu
Contact: Jeffrey Meden, B.S. 734-763-4091

Locations
United States, Michigan
University of Michigan Hospital Recruiting
Ann arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: James R. Corbett, M.D. University of Michigan Hospital
  More Information

No publications provided

Responsible Party: James R. Corbett, M.D., Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT01433705     History of Changes
Other Study ID Numbers: HUM00016183
Study First Received: September 13, 2011
Last Updated: June 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
heart
perfusion
glucose

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases
Fluorodeoxyglucose F18
Diagnostic Uses of Chemicals
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiopharmaceuticals

ClinicalTrials.gov processed this record on October 30, 2014