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The ILLUMINATE Study

Using a fluorescent camera during surgery, nanoparticles illuminate the tumor in this patient's tongue guiding the surgeon during the procedure.

Our clinical research team is conducting a Phase-2 clinical trial with a drug, pegsitacianine based on the fluorescent nanoparticles developed in our lab. This study is to investigate whether pegsitacianine can be used to image head and neck cancers as well as unknown primary cancers (UPC) of the head and neck after being given intravenously. More precise detection of unknown primary cancers and precise delineation of cancer margins can potentially assist surgeons intraoperatively and allow more complete tumor resections. The study is divided into 2 parts:

Part 1

Patients with visible head and neck cancer will be given pegsitacianine before undergoing oncologic surgery and imaged to detect cancer margins.

Part 2

Patients with unknown primary cancer (UPC) of the head and neck will be given pegsitacianine before undergoing exam under anesthesia or laryngoscopy intended to identify their primary cancer.

 

For more details refer to the attached flyer and ClinicalTrials.gov, Identifier: NCT05576974. If you are interested in participating in the trial, please contact the Department of Otolaryngology by phone at research department at Email

Reference:

Fluorescent nanoprobe lights the way to reducing spread of cancer cells | Cancer | Discovery | ENT | UT Southwestern Medical Center 

Selected publications:

  • 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, 13, 204-212. PDF
  • Zhao T, Huang G,Yang S, Ramezani, S, Li Y, Wang Y, Ma X, Xie XJ, Thibodeaux J, Sun X, Sumer BD, Gao J. A Transistor-like pH Nanoprobe for Tumour Detection and Image-Guided Surgery. Nature Biomed. Eng. 2016, 1, 0006. (Featured by Science daily news, Dallas Morning News, NBC5, and CBS11) PDF
  • Huang G, Zhao T, Wang C, Nham K, Xiong Y, Gao X, Wang Y, Hao G, Ge WP, Sun XK, Sumer BD, Gao J. PET Imaging of Occult Tumours by Temporal Integration of Tumour-Acidosis Signals. Nature Biomed. Eng. 2020, 4, 314. PDF
  • Bennett ZT, Feng Q, Bishop JA, Huang G, Sumer BD, Gao J. Detection of Lymph Node Metastases by Ultra-pH-Sensitive Polymeric Nanoparticles. Theranostics. 2020, 10(7), 3340-3350. PDF
  • Voskuil FJ, Steinkamp PJ, Zhao T, van der Begt B, Koller M, Doff JJ, Jayalakshmi Y, Hartung JP, Gao J, Sumer BD, Witjes MJH, van Dam GM. Exploiting metabolic acidosis in solid cancers using a tumor-agnostic pH-activatable nanoprobe for fluorescence-guided surgery. Nature Comm. 2020, 11, 3257. PDF

Baran Sumer, M.D. is cofounder and shareholder of OncoNano Medicine, Inc. which produces pegsitacianine the nanoparticle used for fluorescent guided surgery.