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OtherClinical Investigations (Human)

Biodistribution and radiation dosimetry of 18F-FTC-146 in humans

Trine Hjørnevik, Peter W Cipriano, Bin Shen, Jun Hyung Park, Praveen Gulaka, Dawn Holley, Harsh Gandhi, Daehyun Yoon, Erik S Mittra, Greg Zaharchuk, Sanjiv S Gambhir, Christopher R McCurdy, Frederick T Chin and Sandip Biswal
Journal of Nuclear Medicine June 2017, jnumed.117.192641; DOI: https://doi.org/10.2967/jnumed.117.192641
Trine Hjørnevik
1 Oslo University Hospital, Norway;
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Peter W Cipriano
2 Stanford University, United States;
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Bin Shen
2 Stanford University, United States;
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Jun Hyung Park
2 Stanford University, United States;
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Praveen Gulaka
2 Stanford University, United States;
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Dawn Holley
2 Stanford University, United States;
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Harsh Gandhi
2 Stanford University, United States;
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Daehyun Yoon
2 Stanford University, United States;
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Erik S Mittra
2 Stanford University, United States;
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Greg Zaharchuk
2 Stanford University, United States;
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Sanjiv S Gambhir
2 Stanford University, United States;
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Christopher R McCurdy
3 University of Florida, United States
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Frederick T Chin
2 Stanford University, United States;
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Sandip Biswal
2 Stanford University, United States;
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Abstract

The purpose of this study is to assess safety, biodistribution and radiation dosimetry in humans for the highly selective sigma-1 receptor (S1R) positron emission tomography (PET) agent 18F-6-(3-fluoropropyl)-3-(2-(azepan-1-yl)ethyl)benzo[d]thiazol-2(3H)-one (18F-FTC-146). Methods: Ten healthy volunteers (HV; five female, five male; age: 34.3 ± 6.5 years) were recruited, and written informed consent was obtained from all participants. Series of whole-body PET/magnetic resonance imaging (PET/MRI) examinations were acquired for up to three hours after injection (357.2 ± 48.8 MBq). Blood samples were collected and standard vital signs (heart rate, pulse oximetry, and body temperature) were monitored at regular intervals. Regions-of-interest were delineated, time-activity curves were calculated, and organ uptake and dosimetry was estimated using PMOD 3.7 and Organ Linear Internal Dose Assessment (OLINDA). Results: All subjects tolerated the PET/MRI examination well, and no adverse reactions to 18F-FTC-146 were reported. High accumulation of 18F-FTC-146 was observed in S1R dense organs such as the pancreas and spleen, moderate uptake in the brain and myocardium, and low uptake in bone and muscle. High uptake was also observed in the kidneys and bladder, indicating renal tracer clearance. The effective dose (ED) of 18F-FTC-146 was 0.0259 ± 0.0034 mSv/MBq (range: 0.0215-0.0301 mSv/MBq). Conclusion: First-in-human studies with clinical-grade 18F-FTC-146 were successful. Injection of 18F-FTC-146 is safe, and absorbed doses are acceptable. The potential of 18F-FTC-146 as an imaging agent for a variety of neuroinflammatory diseases is currently under investigation.

  • Molecular Imaging
  • PET
  • Radiobiology/Dosimetry
  • Biodistribution
  • First-in-human
  • PET
  • Radiation dosimetry
  • Sigma-1 receptor
  • Copyright © 2017 by the Society of Nuclear Medicine and Molecular Imaging, Inc.
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Journal of Nuclear Medicine: 64 (5)
Journal of Nuclear Medicine
Vol. 64, Issue 5
May 1, 2023
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Biodistribution and radiation dosimetry of 18F-FTC-146 in humans
Trine Hjørnevik, Peter W Cipriano, Bin Shen, Jun Hyung Park, Praveen Gulaka, Dawn Holley, Harsh Gandhi, Daehyun Yoon, Erik S Mittra, Greg Zaharchuk, Sanjiv S Gambhir, Christopher R McCurdy, Frederick T Chin, Sandip Biswal
Journal of Nuclear Medicine Jun 2017, jnumed.117.192641; DOI: 10.2967/jnumed.117.192641

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Biodistribution and radiation dosimetry of 18F-FTC-146 in humans
Trine Hjørnevik, Peter W Cipriano, Bin Shen, Jun Hyung Park, Praveen Gulaka, Dawn Holley, Harsh Gandhi, Daehyun Yoon, Erik S Mittra, Greg Zaharchuk, Sanjiv S Gambhir, Christopher R McCurdy, Frederick T Chin, Sandip Biswal
Journal of Nuclear Medicine Jun 2017, jnumed.117.192641; DOI: 10.2967/jnumed.117.192641
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Keywords

  • Molecular Imaging
  • PET
  • Radiobiology/Dosimetry
  • Biodistribution
  • First-in-human
  • Radiation dosimetry
  • Sigma-1 receptor
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