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Trial record 5 of 18 for: sumer

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A Phase 2a, Single-dose, Open-label Study to Evaluate Diagnostic Performance and Safety of Pegsitacianine, an Intraoperative Fluorescence Imaging Agent for the Detection of Cancer, in Patients With Unknown Primary Head and Neck Cancer (ILLUMINATE STUDY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT05576974

Recruitment Status : Recruiting

First Posted : October 13, 2022

Last Update Posted : May 9, 2024

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View this study on the modernized ClinicalTrials.gov

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

Baran Sumer, University of Texas Southwestern Medical Center

No Study Results Posted on ClinicalTrials.gov for this Study

About Study Results Reporting on ClinicalTrials.gov

Recruitment Status :	Recruiting
Estimated Primary Completion Date :	December 31, 2027
Estimated Study Completion Date :	December 31, 2027

Publications:

Amit M, Yen TC, Liao CT, Chaturvedi P, Agarwal JP, Kowalski LP, Kohler HF, Ebrahimi A, Clark JR, Cernea CR, Brandao JS, Kreppel M, Zoller JE, Leider-Trejo L, Bachar G, Shpitzer T, Bolzoni AV, Patel RP, Jonnalagadda S, Robbins TK, Shah JP, Patel SG, Gil Z. The origin of regional failure in oral cavity squamous cell carcinoma with pathologically negative neck metastases. JAMA Otolaryngol Head Neck Surg. 2014 Dec;140(12):1130-7. doi: 10.1001/jamaoto.2014.1539.

Dacosta RS, Wilson BC, Marcon NE. Spectroscopy and fluorescence in esophageal diseases. Best Pract Res Clin Gastroenterol. 2006 Feb;20(1):41-57. doi: 10.1016/j.bpg.2005.08.003.

Davies B, Morris T. Physiological parameters in laboratory animals and humans. Pharm Res. 1993 Jul;10(7):1093-5. doi: 10.1023/a:1018943613122. No abstract available.

Denaro N, Russi EG, Adamo V, Merlano MC. State-of-the-art and emerging treatment options in the management of head and neck cancer: news from 2013. Oncology. 2014;86(4):212-29. doi: 10.1159/000357712. Epub 2014 May 10.

d'Alessandro AF, Pinto FR, Lin CS, Kulcsar MA, Cernea CR, Brandao LG, Matos LL. Oral cavity squamous cell carcinoma: factors related to occult lymph node metastasis. Braz J Otorhinolaryngol. 2015 May-Jun;81(3):248-54. doi: 10.1016/j.bjorl.2015.03.004. Epub 2015 Mar 30.

Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9.

Gioux S, Choi HS, Frangioni JV. Image-guided surgery using invisible near-infrared light: fundamentals of clinical translation. Mol Imaging. 2010 Oct;9(5):237-55.

Haka AS, Volynskaya Z, Gardecki JA, Nazemi J, Lyons J, Hicks D, Fitzmaurice M, Dasari RR, Crowe JP, Feld MS. In vivo margin assessment during partial mastectomy breast surgery using raman spectroscopy. Cancer Res. 2006 Mar 15;66(6):3317-22. doi: 10.1158/0008-5472.CAN-05-2815.

Jonkman A, Kaanders JH, Terhaard CH, Hoebers FJ, van den Ende PL, Wijers OB, Verhoef LC, de Jong MA, Leemans CR, Langendijk JA. Multicenter validation of recursive partitioning analysis classification for patients with squamous cell head and neck carcinoma treated with surgery and postoperative radiotherapy. Int J Radiat Oncol Biol Phys. 2007 May 1;68(1):119-25. doi: 10.1016/j.ijrobp.2006.12.002.

Kim T, Giuliano AE, Lyman GH. Lymphatic mapping and sentinel lymph node biopsy in early-stage breast carcinoma: a metaanalysis. Cancer. 2006 Jan 1;106(1):4-16. doi: 10.1002/cncr.21568.

Koller M, Qiu SQ, Linssen MD, Jansen L, Kelder W, de Vries J, Kruithof I, Zhang GJ, Robinson DJ, Nagengast WB, Jorritsma-Smit A, van der Vegt B, van Dam GM. Implementation and benchmarking of a novel analytical framework to clinically evaluate tumor-specific fluorescent tracers. Nat Commun. 2018 Sep 18;9(1):3739. doi: 10.1038/s41467-018-05727-y.

Kumar R, Roy I, Ohulchanskky TY, Vathy LA, Bergey EJ, Sajjad M, Prasad PN. In vivo biodistribution and clearance studies using multimodal organically modified silica nanoparticles. ACS Nano. 2010 Feb 23;4(2):699-708. doi: 10.1021/nn901146y.

Li Y, Zhao T, Wang C, Lin Z, Huang G, Sumer BD, Gao J. Erratum: Molecular basis of cooperativity in pH-triggered supramolecular self-assembly. Nat Commun. 2016 Dec 16;7:13777. doi: 10.1038/ncomms13777. No abstract available.

Ma X, Wang Y, Zhao T, Li Y, Su LC, Wang Z, Huang G, Sumer BD, Gao J. Ultra-pH-sensitive nanoprobe library with broad pH tunability and fluorescence emissions. J Am Chem Soc. 2014 Aug 6;136(31):11085-92. doi: 10.1021/ja5053158. Epub 2014 Jul 29.

Milenovic A, Virag M, Knezevic P, Boras VV, Ostovic KT, Panduric DG, Susic M. Evaluation of sentinel node biopsy in oral carcinomas. Coll Antropol. 2014 Mar;38(1):279-82.

Mo J, Zheng W, Low JJ, Ng J, Ilancheran A, Huang Z. High wavenumber Raman spectroscopy for in vivo detection of cervical dysplasia. Anal Chem. 2009 Nov 1;81(21):8908-15. doi: 10.1021/ac9015159.

Pedersen NJ, Jensen DH, Hedback N, Frendo M, Kiss K, Lelkaitis G, Mortensen J, Christensen A, Specht L, von Buchwald C. Staging of early lymph node metastases with the sentinel lymph node technique and predictive factors in T1/T2 oral cavity cancer: A retrospective single-center study. Head Neck. 2016 Apr;38 Suppl 1:E1033-40. doi: 10.1002/hed.24153. Epub 2015 Sep 2.

Rosenthal EL, Warram JM, de Boer E, Basilion JP, Biel MA, Bogyo M, Bouvet M, Brigman BE, Colson YL, DeMeester SR, Gurtner GC, Ishizawa T, Jacobs PM, Keereweer S, Liao JC, Nguyen QT, Olson JM, Paulsen KD, Rieves D, Sumer BD, Tweedle MF, Vahrmeijer AL, Weichert JP, Wilson BC, Zenn MR, Zinn KR, van Dam GM. Successful Translation of Fluorescence Navigation During Oncologic Surgery: A Consensus Report. J Nucl Med. 2016 Jan;57(1):144-50. doi: 10.2967/jnumed.115.158915. Epub 2015 Oct 8.

Schwarz RA, Gao W, Redden Weber C, Kurachi C, Lee JJ, El-Naggar AK, Richards-Kortum R, Gillenwater AM. Noninvasive evaluation of oral lesions using depth-sensitive optical spectroscopy. Cancer. 2009 Apr 15;115(8):1669-79. doi: 10.1002/cncr.24177.

Sibille M, Patat A, Caplain H, Donazzolo Y. A safety grading scale to support dose escalation and define stopping rules for healthy subject first-entry-into-man studies: some points to consider from the French Club Phase I working group. Br J Clin Pharmacol. 2010 Nov;70(5):736-48. doi: 10.1111/j.1365-2125.2010.03741.x.

Thompson CF, St John MA, Lawson G, Grogan T, Elashoff D, Mendelsohn AH. Diagnostic value of sentinel lymph node biopsy in head and neck cancer: a meta-analysis. Eur Arch Otorhinolaryngol. 2013 Jul;270(7):2115-22. doi: 10.1007/s00405-012-2320-0. Epub 2012 Dec 22.

Vahrmeijer AL, Hutteman M, van der Vorst JR, van de Velde CJ, Frangioni JV. Image-guided cancer surgery using near-infrared fluorescence. Nat Rev Clin Oncol. 2013 Sep;10(9):507-18. doi: 10.1038/nrclinonc.2013.123. Epub 2013 Jul 23.

Wang Y, Zhou K, Huang G, Hensley C, Huang X, Ma X, Zhao T, Sumer BD, DeBerardinis RJ, Gao J. A nanoparticle-based strategy for the imaging of a broad range of tumours by nonlinear amplification of microenvironment signals. Nat Mater. 2014 Feb;13(2):204-12. doi: 10.1038/nmat3819. Epub 2013 Dec 8.

Webb BA, Chimenti M, Jacobson MP, Barber DL. Dysregulated pH: a perfect storm for cancer progression. Nat Rev Cancer. 2011 Aug 11;11(9):671-7. doi: 10.1038/nrc3110.

Zhao T, Huang G, Li Y, Yang S, Ramezani S, Lin Z, Wang Y, Ma X, Zeng Z, Luo M, de Boer E, Xie XJ, Thibodeaux J, Brekken RA, Sun X, Sumer BD, Gao J. A Transistor-like pH Nanoprobe for Tumour Detection and Image-guided Surgery. Nat Biomed Eng. 2016;1:0006. doi: 10.1038/s41551-016-0006. Epub 2016 Dec 19.