Einzeltreffer — DigiBib

Tumor-positive resection margins are present in up to 23% of head and neck cancer (HNC) surgeries, as intraoperative techniques for real-time evaluation of the resection margins are lacking. In this study, we investigated the safety and potential clinical value of fluorescence-guided imaging (FGI) for resection margin evaluation in HNC patients. We determined the optimal cetuximab-800CW dose by quantification of intrinsic fluorescence values using multi-diameter single-fiber reflectance, single-fiber fluorescence (MDSFR/SFF) spectroscopy. Methods : Five cohorts of three HNC patients received cetuximab-800CW systemically: three single dose cohorts (10, 25, 50 mg) and two cohorts pre-dosed with 75 mg unlabeled cetuximab (15 or 25 mg). Fluorescence visualization and MDSFR/SFF spectroscopy quantification was performed and were correlated to histopathology. Results : There were no study-related adverse events higher than Common Terminology Criteria for Adverse Events grade-II. Quantification of intrinsic fluorescence values showed a dose-dependent increase in background fluorescence in the single dose cohorts ( p<0.001, p<0.001 ), which remained consistently low in the pre-dosed cohorts (p=0.6808) . Resection margin status was evaluated with a sensitivity of 100% (4/4 tumor-positive margins) and specificity of 91% (10/11 tumor-negative margins). Conclusion : A pre-dose of 75 mg unlabeled cetuximab followed by 15 mg cetuximab-800CW was considered the optimal dose based on safety, fluorescence visualization and quantification of intrinsic fluorescence values. We were able to use a lower dose cetuximab-800CW than previously described, while remaining a high sensitivity for tumor detection due to application of equipment optimized for IRDye800CW detection, which was validated by quantification of intrinsic fluorescence values.

Competing Interests: Competing Interests: GMvD is member of the Scientific Advisory Board of SurgVision BV, and CEO, founder and shareholder of TRACER Europe BV / AxelarX. GMvD and WBN received an unrestricted research grant from SurgVision BV.

Titel:	Fluorescence-guided imaging for resection margin evaluation in head and neck cancer patients using cetuximab-800CW: A quantitative dose-escalation study.
Autor/in / Beteiligte Person:	Voskuil, FJ ; de Jongh SJ ; Hooghiemstra, WTR ; Linssen, MD ; Steinkamp, PJ ; de Visscher SAHJ ; Schepman, KP ; Elias, SG ; Meersma, GJ ; Jonker, PKC ; Doff, JJ ; Jorritsma-Smit, A ; Nagengast, WB ; van der Vegt B ; Robinson, DJ ; van Dam GM ; Witjes, MJH
Link:	Full Text Finder (Volltext)
Zeitschrift:	Theranostics, Jg. 10 (2020-03-04), Heft 9, S. 3994-4005
Veröffentlichung:	Wyoming, N.S.W. : Ivyspring International Publisher, 2011-, 2020
Medientyp:	academicJournal
ISSN:	1838-7640 (electronic)
DOI:	10.7150/thno.43227
Schlagwort:	Aged Aged, 80 and over Cohort Studies Female Fluorescent Dyes chemistry Humans Male Margins of Excision Middle Aged Antineoplastic Agents, Immunological administration & dosage Benzenesulfonates administration & dosage Cetuximab administration & dosage Head and Neck Neoplasms surgery Indoles administration & dosage Optical Imaging Surgery, Computer-Assisted
Sonstiges:	Nachgewiesen in: MEDLINE Sprachen: English Publication Type: Clinical Trial, Phase I; Journal Article; Research Support, Non-U.S. Gov't Language: English [Theranostics] 2020 Mar 04; Vol. 10 (9), pp. 3994-4005. <i>Date of Electronic Publication: </i>2020 Mar 04 (<i>Print Publication: </i>2020). MeSH Terms: Optical Imaging* ; Surgery, Computer-Assisted* ; Antineoplastic Agents, Immunological / administration & dosage ; Benzenesulfonates / administration & dosage ; Cetuximab / administration & dosage ; Head and Neck Neoplasms / surgery ; Indoles / *administration & dosage ; Aged ; Aged, 80 and over ; Cohort Studies ; Female ; Fluorescent Dyes / chemistry ; Humans ; Male ; Margins of Excision ; Middle Aged References: Ann Surg Oncol. 2018 Jul;25(7):1880-1888. (PMID: 29667116) ; Ann Surg Oncol. 2011 Mar;18(3):603-7. (PMID: 21161729) ; CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. (PMID: 21296855) ; Annu Rev Med. 2016;67:153-64. (PMID: 26768238) ; Nat Med. 2015 Aug;21(8):955-61. (PMID: 26168295) ; Oral Oncol. 2005 Nov;41(10):1034-43. (PMID: 16129652) ; Gut. 2019 Jan;68(1):7-10. (PMID: 29247063) ; Br J Oral Maxillofac Surg. 2003 Aug;41(4):224-31. (PMID: 12946663) ; Opt Lett. 2012 Mar 1;37(5):948-50. (PMID: 22378448) ; Oral Oncol. 2007 Sep;43(8):780-4. (PMID: 17174145) ; Mol Imaging Biol. 2020 Feb;22(1):156-164. (PMID: 31054001) ; Lancet Gastroenterol Hepatol. 2016 Dec;1(4):283-290. (PMID: 28404198) ; Cancer Res. 2018 Sep 1;78(17):5144-5154. (PMID: 29967260) ; Theranostics. 2018 Mar 28;8(9):2488-2495. (PMID: 29721094) ; Theranostics. 2018 Feb 5;8(6):1458-1467. (PMID: 29556334) ; Cancer Res. 1993 Aug 1;53(15):3579-84. (PMID: 8339264) ; Oral Oncol. 2019 Jan;88:58-65. (PMID: 30616798) ; J Nucl Med. 2019 Mar;60(3):418-423. (PMID: 30630938) ; Br J Oral Maxillofac Surg. 2012 Mar;50(2):102-8. (PMID: 21742422) ; Cancer Res. 2002 Dec 15;62(24):7350-6. (PMID: 12499279) ; Nat Methods. 2005 Dec;2(12):932-40. (PMID: 16299478) ; Head Neck. 2020 Jan;42(1):59-66. (PMID: 31571335) ; J Biomed Opt. 2014 Jan;19(1):15010. (PMID: 24477382) ; J Nucl Med. 2019 Oct 18;:. (PMID: 31628218) ; Clin Cancer Res. 2019 Aug 1;25(15):4656-4662. (PMID: 31142505) ; Clin Cancer Res. 2015 Aug 15;21(16):3658-66. (PMID: 25904751) ; Sci Rep. 2015 Jun 29;5:10169. (PMID: 26120042) ; Nat Commun. 2018 Sep 18;9(1):3739. (PMID: 30228269) ; Int J Oral Maxillofac Surg. 2003 Feb;32(1):30-4. (PMID: 12653229) ; J Biomed Opt. 2012 Jun;17(6):067001. (PMID: 22734779) ; Clin Cancer Res. 2017 Jun 1;23(11):2730-2741. (PMID: 28119364) ; Sci Rep. 2018 Apr 9;8(1):5686. (PMID: 29632347) ; Mol Imaging Biol. 2017 Aug;19(4):610-616. (PMID: 27830425) ; Arch Pathol Lab Med. 1996 Sep;120(9):804-9. (PMID: 9140284) ; Nat Med. 2011 Sep 18;17(10):1315-9. (PMID: 21926976) ; J Dermatol Sci. 2015 Jul;79(1):64-73. (PMID: 25911633) ; Biomed Opt Express. 2013 Apr 09;4(5):696-708. (PMID: 23667786) ; Head Neck. 2018 May;40(5):963-972. (PMID: 29356187) Contributed Indexing: Keywords: MDSFR/SFF spectroscopy; cetuximab-800CW; fluorescence-guided imaging; head and neck cancer; intrinsic fluorescence Substance Nomenclature: 0 (Antineoplastic Agents, Immunological) ; 0 (Benzenesulfonates) ; 0 (Fluorescent Dyes) ; 0 (IRDye 800CW) ; 0 (Indoles) ; PQX0D8J21J (Cetuximab) Entry Date(s): Date Created: 20200401 Date Completed: 20210518 Latest Revision: 20210518 Update Code: 20231215 PubMed Central ID: PMC7086353

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Fluorescence-guided imaging for resection margin evaluation in head and neck cancer patients using cetuximab-800CW: A quantitative dose-escalation study.