Intraoperative Imaging of Pituitary Adenomas by OTL

Summary

The primary end-point of the study is to determine the specificity and sensitivity of OTL38 in identifying pituitary adenomas when excited by an imaging probe. The investigators intend to enroll 50 patients in this study. The study is focusing on patients presenting with suspected pituitary adenomas who are considered to be good surgical candidates.

Timeline

Start

2015-10

Primary completion

2018-08-03

Completion

2018-08-03

Outcome

Outcome not reported

Stopped (Enrollment): “Recruitment Fulfilled”

Publications

• Background Liu X, Ma S, Yao Y, Li G, Feng M, Deng K, Dai C, Cai F, Li Y, Zhang B, Wang R. Differential expression of folate receptor alpha in pituitary adenomas and its relationship to tumor behavior. Neurosurgery. 2012 May;70(5):1274-80; discussion 1280. doi: 10.1227/NEU.0b013e3182417e76.
• Background Evans CO, Yao C, Laborde D, Oyesiku NM. Folate receptor expression in pituitary adenomas cellular and molecular analysis. Vitam Horm. 2008;79:235-66. doi: 10.1016/S0083-6729(08)00408-1.
• Background Evans CO, Reddy P, Brat DJ, O'Neill EB, Craige B, Stevens VL, Oyesiku NM. Differential expression of folate receptor in pituitary adenomas. Cancer Res. 2003 Jul 15;63(14):4218-24.
• Background Feng Y, Shen J, Streaker ED, Lockwood M, Zhu Z, Low PS, Dimitrov DS. A folate receptor beta-specific human monoclonal antibody recognizes activated macrophage of rheumatoid patients and mediates antibody-dependent cell-mediated cytotoxicity. Arthritis Res Ther. 2011 Apr 8;13(2):R59. doi: 10.1186/ar3312.
• Background Hilgenbrink AR, Low PS. Folate receptor-mediated drug targeting: from therapeutics to diagnostics. J Pharm Sci. 2005 Oct;94(10):2135-46. doi: 10.1002/jps.20457.
• Background Kennedy MD, Jallad KN, Thompson DH, Ben-Amotz D, Low PS. Optical imaging of metastatic tumors using a folate-targeted fluorescent probe. J Biomed Opt. 2003 Oct;8(4):636-41. doi: 10.1117/1.1609453.
• Background Low PS, Antony AC. Folate receptor-targeted drugs for cancer and inflammatory diseases. Adv Drug Deliv Rev. 2004 Apr 29;56(8):1055-8. doi: 10.1016/j.addr.2004.02.003. No abstract available.
• Background Xia W, Low PS. Folate-targeted therapies for cancer. J Med Chem. 2010 Oct 14;53(19):6811-24. doi: 10.1021/jm100509v. No abstract available.
• Background Lu Y, Sega E, Leamon CP, Low PS. Folate receptor-targeted immunotherapy of cancer: mechanism and therapeutic potential. Adv Drug Deliv Rev. 2004 Apr 29;56(8):1161-76. doi: 10.1016/j.addr.2004.01.009.
• Background Lu Y, Xu LC, Parker N, Westrick E, Reddy JA, Vetzel M, Low PS, Leamon CP. Preclinical pharmacokinetics, tissue distribution, and antitumor activity of a folate-hapten conjugate-targeted immunotherapy in hapten-immunized mice. Mol Cancer Ther. 2006 Dec;5(12):3258-67. doi: 10.1158/1535-7163.MCT-06-0439.
• Background Paulos CM, Reddy JA, Leamon CP, Turk MJ, Low PS. Ligand binding and kinetics of folate receptor recycling in vivo: impact on receptor-mediated drug delivery. Mol Pharmacol. 2004 Dec;66(6):1406-14. doi: 10.1124/mol.104.003723. Epub 2004 Sep 15.
• Background Stephenson SM, Low PS, Lee RJ. Folate receptor-mediated targeting of liposomal drugs to cancer cells. Methods Enzymol. 2004;387:33-50. doi: 10.1016/S0076-6879(04)87003-4. No abstract available.
• Background Yang J, Chen H, Vlahov IR, Cheng JX, Low PS. Characterization of the pH of folate receptor-containing endosomes and the rate of hydrolysis of internalized acid-labile folate-drug conjugates. J Pharmacol Exp Ther. 2007 May;321(2):462-8. doi: 10.1124/jpet.106.117648. Epub 2007 Feb 8.
• Background Dorward NL. Endocrine outcomes in endoscopic pituitary surgery: a literature review. Acta Neurochir (Wien). 2010 Aug;152(8):1275-9. doi: 10.1007/s00701-010-0649-y. Epub 2010 May 10.
• Background Swearingen B. Update on pituitary surgery. J Clin Endocrinol Metab. 2012 Apr;97(4):1073-81. doi: 10.1210/jc.2011-3237. Epub 2012 Feb 15.
• Background Berkmann S, Schlaffer S, Nimsky C, Fahlbusch R, Buchfelder M. Follow-up and long-term outcome of nonfunctioning pituitary adenoma operated by transsphenoidal surgery with intraoperative high-field magnetic resonance imaging. Acta Neurochir (Wien). 2014 Dec;156(12):2233-43; discussion 2243. doi: 10.1007/s00701-014-2210-x. Epub 2014 Sep 2.
• Background Sylvester PT, Evans JA, Zipfel GJ, Chole RA, Uppaluri R, Haughey BH, Getz AE, Silverstein J, Rich KM, Kim AH, Dacey RG, Chicoine MR. Combined high-field intraoperative magnetic resonance imaging and endoscopy increase extent of resection and progression-free survival for pituitary adenomas. Pituitary. 2015 Feb;18(1):72-85. doi: 10.1007/s11102-014-0560-2.

Drugs

Indications