Schreiber, Wilson
Petryakov, Sergey V.
Kmiec, Maciej M.
Flood, Ann Barry http://orcid.org/0000-0002-4035-3084
Swartz, Harold M. http://orcid.org/0000-0001-6057-6587
Schaner, Philip E. http://orcid.org/0000-0002-5239-1950
Williams, Benjamin B. http://orcid.org/0000-0003-4330-6256
Funding for this research was provided by:
National Cancer Institute (CA190193)
Article History
Received: 22 January 2021
Revised: 31 May 2021
Accepted: 30 June 2021
First Online: 7 August 2021
Declarations
:
: Harold Swartz and Ann Flood are co-owners of Clin-EPR, LLC which manufactures clinical and preclinical EPR spectrometers for investigational use only. No other authors declare a conflict of interest.
: Although no preclinical or clinical studies using this equipment are reported here, all studies using animals or human subjects had been approved by the appropriate Institutional Research Boards (IRB) or Institutional Animal Care and Use Committees (IACUC) where the studies were conducted. All human subjects gave written informed consent to participate. All IRBs where the EPR spectroscopy devices were used in studies determined that they were non-significant risk devices and therefore do not require an Institutional Device Exemption (IDE) from the Food and Drug Administration. Some implanted oxygen sensors were required to have an IDE prior to first use in humans.