First-In-Human Study in Cancer Patients Establishing the Feasibility of Oxygen Measurements in Tumors Using Electron Paramagnetic Resonance With the OxyChip.

Autor:	Schaner PE; Department of Medicine, Norris Cotton Cancer Center, Geisel School of Medicine at Dartmouth College, and Dartmouth-Hitchcock Medical Center, Lebanon, NH, United States., Williams BB; Department of Medicine, Norris Cotton Cancer Center, Geisel School of Medicine at Dartmouth College, and Dartmouth-Hitchcock Medical Center, Lebanon, NH, United States.; Department of Radiology, Norris Cotton Cancer Center, Geisel School of Medicine at Dartmouth College, and Dartmouth-Hitchcock Medical Center, Lebanon, NH, United States., Chen EY; Department of Surgery, Norris Cotton Cancer Center, Geisel School of Medicine at Dartmouth College, and Dartmouth-Hitchcock Medical Center, Lebanon, NH, United States., Pettus JR; Department of Pathology, Norris Cotton Cancer Center, Geisel School of Medicine at Dartmouth College, and Dartmouth-Hitchcock Medical Center, Lebanon, NH, United States., Schreiber WA; Department of Radiology, Norris Cotton Cancer Center, Geisel School of Medicine at Dartmouth College, and Dartmouth-Hitchcock Medical Center, Lebanon, NH, United States., Kmiec MM; Department of Radiology, Norris Cotton Cancer Center, Geisel School of Medicine at Dartmouth College, and Dartmouth-Hitchcock Medical Center, Lebanon, NH, United States., Jarvis LA; Department of Medicine, Norris Cotton Cancer Center, Geisel School of Medicine at Dartmouth College, and Dartmouth-Hitchcock Medical Center, Lebanon, NH, United States., Pastel DA; Department of Radiology, Norris Cotton Cancer Center, Geisel School of Medicine at Dartmouth College, and Dartmouth-Hitchcock Medical Center, Lebanon, NH, United States., Zuurbier RA; Department of Radiology, Norris Cotton Cancer Center, Geisel School of Medicine at Dartmouth College, and Dartmouth-Hitchcock Medical Center, Lebanon, NH, United States., DiFlorio-Alexander RM; Department of Radiology, Norris Cotton Cancer Center, Geisel School of Medicine at Dartmouth College, and Dartmouth-Hitchcock Medical Center, Lebanon, NH, United States., Paydarfar JA; Department of Surgery, Norris Cotton Cancer Center, Geisel School of Medicine at Dartmouth College, and Dartmouth-Hitchcock Medical Center, Lebanon, NH, United States., Gosselin BJ; Department of Surgery, Norris Cotton Cancer Center, Geisel School of Medicine at Dartmouth College, and Dartmouth-Hitchcock Medical Center, Lebanon, NH, United States., Barth RJ; Department of Surgery, Norris Cotton Cancer Center, Geisel School of Medicine at Dartmouth College, and Dartmouth-Hitchcock Medical Center, Lebanon, NH, United States., Rosenkranz KM; Department of Surgery, Norris Cotton Cancer Center, Geisel School of Medicine at Dartmouth College, and Dartmouth-Hitchcock Medical Center, Lebanon, NH, United States., Petryakov SV; Department of Radiology, Norris Cotton Cancer Center, Geisel School of Medicine at Dartmouth College, and Dartmouth-Hitchcock Medical Center, Lebanon, NH, United States., Hou H; Department of Radiology, Norris Cotton Cancer Center, Geisel School of Medicine at Dartmouth College, and Dartmouth-Hitchcock Medical Center, Lebanon, NH, United States., Tse D; Department of Radiology, Norris Cotton Cancer Center, Geisel School of Medicine at Dartmouth College, and Dartmouth-Hitchcock Medical Center, Lebanon, NH, United States., Pletnev A; Department of Chemistry, Norris Cotton Cancer Center, Geisel School of Medicine at Dartmouth College, and Dartmouth-Hitchcock Medical Center, Lebanon, NH, United States., Flood AB; Department of Radiology, Norris Cotton Cancer Center, Geisel School of Medicine at Dartmouth College, and Dartmouth-Hitchcock Medical Center, Lebanon, NH, United States., Wood VA; Department of Radiology, Norris Cotton Cancer Center, Geisel School of Medicine at Dartmouth College, and Dartmouth-Hitchcock Medical Center, Lebanon, NH, United States., Hebert KA; Department of Radiology, Norris Cotton Cancer Center, Geisel School of Medicine at Dartmouth College, and Dartmouth-Hitchcock Medical Center, Lebanon, NH, United States., Mosher RE; Department of Radiology, Norris Cotton Cancer Center, Geisel School of Medicine at Dartmouth College, and Dartmouth-Hitchcock Medical Center, Lebanon, NH, United States., Demidenko E; Department of Biomedical Data Science, Norris Cotton Cancer Center, Geisel School of Medicine at Dartmouth College, and Dartmouth-Hitchcock Medical Center, Lebanon, NH, United States., Swartz HM; Department of Radiology, Norris Cotton Cancer Center, Geisel School of Medicine at Dartmouth College, and Dartmouth-Hitchcock Medical Center, Lebanon, NH, United States., Kuppusamy P; Department of Medicine, Norris Cotton Cancer Center, Geisel School of Medicine at Dartmouth College, and Dartmouth-Hitchcock Medical Center, Lebanon, NH, United States.; Department of Radiology, Norris Cotton Cancer Center, Geisel School of Medicine at Dartmouth College, and Dartmouth-Hitchcock Medical Center, Lebanon, NH, United States.; Department of Chemistry, Norris Cotton Cancer Center, Geisel School of Medicine at Dartmouth College, and Dartmouth-Hitchcock Medical Center, Lebanon, NH, United States.
Jazyk:	angličtina
Zdroj:	Frontiers in oncology [Front Oncol] 2021 Oct 01; Vol. 11, pp. 743256. Date of Electronic Publication: 2021 Oct 01 (Print Publication: 2021).
DOI:	10.3389/fonc.2021.743256
Abstrakt:	Objective: The overall objective of this clinical study was to validate an implantable oxygen sensor, called the 'OxyChip', as a clinically feasible technology that would allow individualized tumor-oxygen assessments in cancer patients prior to and during hypoxia-modification interventions such as hyperoxygen breathing. Methods: Patients with any solid tumor at ≤3-cm depth from the skin-surface scheduled to undergo surgical resection (with or without neoadjuvant therapy) were considered eligible for the study. The OxyChip was implanted in the tumor and subsequently removed during standard-of-care surgery. Partial pressure of oxygen (pO 2 ) at the implant location was assessed using electron paramagnetic resonance (EPR) oximetry. Results: Twenty-three cancer patients underwent OxyChip implantation in their tumors. Six patients received neoadjuvant therapy while the OxyChip was implanted. Median implant duration was 30 days (range 4-128 days). Forty-five successful oxygen measurements were made in 15 patients. Baseline pO 2 values were variable with overall median 15.7 mmHg (range 0.6-73.1 mmHg); 33% of the values were below 10 mmHg. After hyperoxygenation, the overall median pO 2 was 31.8 mmHg (range 1.5-144.6 mmHg). In 83% of the measurements, there was a statistically significant (p ≤ 0.05) response to hyperoxygenation. Conclusions: Measurement of baseline pO 2 and response to hyperoxygenation using EPR oximetry with the OxyChip is clinically feasible in a variety of tumor types. Tumor oxygen at baseline differed significantly among patients. Although most tumors responded to a hyperoxygenation intervention, some were non-responders. These data demonstrated the need for individualized assessment of tumor oxygenation in the context of planned hyperoxygenation interventions to optimize clinical outcomes. Competing Interests: PK has multiple patents issued for OxyChip; but declares no competing interest. AF and HS are co-owners of Clin-EPR, a company that sells EPR spectrometers for research use in human subjects. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. (Copyright © 2021 Schaner, Williams, Chen, Pettus, Schreiber, Kmiec, Jarvis, Pastel, Zuurbier, DiFlorio-Alexander, Paydarfar, Gosselin, Barth, Rosenkranz, Petryakov, Hou, Tse, Pletnev, Flood, Wood, Hebert, Mosher, Demidenko, Swartz and Kuppusamy.)
Databáze:	MEDLINE
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