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Dosimetry, biodistribution, and safety of flurpiridaz F 18 in healthy subjects undergoing rest and exercise or pharmacological stress PET myocardial perfusion imaging

  • Jamshid MaddahiEmail author
  • Frank Bengel
  • Johannes Czernin
  • Paul Crane
  • Magnus Dahlbom
  • Heinrich Schelbert
  • Richard Sparks
  • Michael Phelps
  • Joel Lazewatsky
Original Article

Abstract

The objectives of this study were to evaluate radiation dosimetry, biodistribution, human safety, and tolerability of 18F-labeled flurpiridaz (Flurpiridaz) in normal subjects undergoing rest and separate-day exercise or adenosine pharmacological stress PET imaging.

Methods

12 normal subjects were injected with 58.5 to 121 MBq (1.58 to 3.27 mCi) of Flurpiridaz intravenously at rest on Day 1 and 57 to 171 MBq (1.54 to 4.61 mCi) during stress on Day 2. Sequential whole-body imaging was performed for 5 hours. Blood samples were collected for up to 8 hours.

Results

The heart wall received the largest mean absorbed dose with both exercise and adenosine stresses. The mean effective dose was 0.054 rem/mCi (0.015 mSv/MBq) with exercise and 0.069 rem/mCi (0.019 mSv/MBq) with adenosine pharmacological stress. The maximum dose that may be administered without exceeding 1 rem (10 mSv) effective dose was 19 mCi (685 MBq) for exercise and 15 mCi (539 MBq) for adenosine pharmacological stress. There were no drug-related adverse events, and the tracer was well tolerated in all subjects.

Conclusion

Based on radiation dosimetry, biodistribution, and safety observations, 18F-labeled flurpiridaz is found suitable for clinical PET myocardial perfusion imaging in conjunction with either exercise or pharmacological stress testing.

Keywords

Flurpiridaz dosimetry and biodistribution myocardial perfusion PET imaging exercise cardiac PET imaging safety 

Abbreviations

Flurpiridaz

F-18-labeled flurpiridaz (flurpiridaz F 18)

PET

Positron emission tomography

MBq

Megabecquerel

mCi

Millicurie

rem

Roentgen equivalent man

mSv

Millisievert

MPI

Myocardial perfusion imaging

ECG

Electrocardiogram

EEG

Electroencephalogram

BMI

Body mass index

DE

Dosimetry estimate

ED

Effective dose

%ID

Percent injected dose

ROI

Region of interest

AE

Adverse event

SD

Standard deviation

Notes

Acknowledgements

The authors wish to acknowledge the assistances of Jean-Richard Eugene, CNMT in PET image acquisition and processing, Deborah Dorsey, RN, and Parham Naghdechi, MD in the recruitment and monitoring of the research subjects. The authors are grateful to Susan Ramsey for analyzing the data and for helpful comments on drafts of the manuscript. Financial support for this study was provided by Lantheus Medical Imaging, Billerica, MA.

Disclosure

Jamshid Maddahi is the Chair of the Steering Committee, Member of the Scientific Advisory Board and received grant funding from Lantheus Medical Imaging (LMI) for this study. Frank Bengel and Richard Sparks received grant funding from LMI. Paul Crane and Joel Lazewatsky are employees of LMI. Johannes Czernin, Magnus Dahlbom, Heinrich Schelbert, and Michael Phelps declare that they have no conflict of interest related to this study.

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Copyright information

© American Society of Nuclear Cardiology 2018

Authors and Affiliations

  • Jamshid Maddahi
    • 1
    • 2
    Email author
  • Frank Bengel
    • 3
    • 6
  • Johannes Czernin
    • 1
  • Paul Crane
    • 4
  • Magnus Dahlbom
    • 1
  • Heinrich Schelbert
    • 1
  • Richard Sparks
    • 5
  • Michael Phelps
    • 1
  • Joel Lazewatsky
    • 4
  1. 1.Department of Molecular and Medical Pharmacology (Nuclear Medicine)David Geffen School of Medicine at University of California, Los Angeles (UCLA)Los AngelesUSA
  2. 2.Department of Medicine (Cardiology)David Geffen School of Medicine at University of California, Los Angeles (UCLA)Los AngelesUSA
  3. 3.The Johns Hopkins Medical InstitutionsBaltimoreUSA
  4. 4.Lantheus Medical ImagingBillericaUSA
  5. 5.CDE Dosimetry ServicesKnoxvilleUSA
  6. 6.Medizinische Hochschule HannoverHannoverGermany

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